Tacrolimus Eye Ointment Research Articles

To evaluate the effects of the application of 0.03% tacrolimus ointment in patients of vernal keratoconjunctivitis at a tertiary care hospital

Context: The aim of this study was to evaluate the effect of the application of 0.03% tacrolimus eye ointment in treating patients diagnosed with vernal keratoconjunctivitis (VKC) specifically within a tertiary care hospital setting. Materials and Methods: From October 2019 to October 2021, a prospective observational study took place at the department of ophthalmology in a tertiary care center. The study involved 42 consecutive VKC cases that had not seen relief with antihistaminics, mast cell stabilizers, or topical steroids. When steroid is applied in VKC patient it leads to various complications. So, in steroid refractory VKC tacrolimus application is used. Treatment involved applying topical 0.03% tacrolimus ointment was an effective and safe treatment. The study assessed changes in symptoms and signs posttreatment and monitored potential complications at 1, 4, 7, 10, and 14 weeks into the treatment during follow-up sessions. Results: The mean age of the patients was 10.7 ± 3.3 years. Following the administration of 0.03% tacrolimus, all signs and symptoms such as itching, foreign body sensation, tearing, photophobia, papillae, conjunctival hyperemia, limbal edema, Horner-Trantas dots, as well as keratitis (superficial punctate keratitis) showed significant improvement (P < 0.001). Conclusion: The application of 0.03% tacrolimus has been found effective in reducing the symptoms and signs of VKC, particularly in cases refractory to steroids, with very few cases reporting minimal side effects. This study emphasizes the crucial role of tacrolimus in preventing the severe visual complications often linked to this disease.

Effect of Topical (0.03%) Tacrolimus Eye Ointment in the Management of Vernal Keratoconjunctivitis

Background: Vernal keratoconjunctivitis (VKC) is a chronic, severe ocular inflammatory disorder predominantly affecting children and young adults. Current treatments, including antihistamines and corticosteroids, can have significant side effects, particularly with long-term use. Tacrolimus, a macrolide immunosuppressant, has emerged as a promising alternative due to its ability to inhibit T-cell proliferation and cytokine release, key factors in VKC pathogenesis. Objective: To determine the efficacy and safety of 0.03% tacrolimus eye ointment in the management of vernal keratoconjunctivitis compared to standard steroid-based treatment. Methods: This quasi-experimental study was conducted at the Department of Ophthalmology, Pak-Emirates Military Hospital, Rawalpindi, from January 2022 to May 2024. A total of 40 patients (80 eyes) diagnosed with VKC were included. Patients aged 5 to 60 years with bilateral VKC and no prior treatment in the last month were enrolled. Exclusion criteria included concurrent eye infections, use of contact lenses, systemic comorbidities, and previous ocular surgeries. The intervention group received 0.03% tacrolimus ointment twice daily for two months, followed by once daily for two months, and then on alternate days for the final two months. The control group received a combination of 0.1% fluorometholone eye drops, 0.3% tobramycin/0.1% dexamethasone ointment, and 0.1% olopatadine, with steroid tapering after two weeks. Patients were followed up at two weeks, one month, three months, and six months. The primary outcome was the change in symptom and sign scores from baseline to six months. Data were analyzed using SPSS version 25, with statistical significance set at p≤0.05. Results: The median age of the study population was 15.50 years (IQR: 10.00), with 57.4% female. The tacrolimus group showed significant improvement in eye discharge (p=0.033), itching (p=0.004), lacrimation (p=0.008), and foreign body sensation (p=0.015) compared to the control group. The average symptom score decreased more significantly in the tacrolimus group (p<0.001). Clinical signs such as punctate keratitis (p=0.031) and papillae (p=0.018) also showed greater resolution in the tacrolimus group, with a significant reduction in the average sign score (p=0.009). Conclusion: Topical 0.03% tacrolimus eye ointment is an effective and safe treatment for VKC, providing superior symptom relief and clinical improvement compared to standard steroid-based therapy. It offers a promising alternative for long-term management of VKC, with fewer side effects than traditional corticosteroids.

Tear Tacrolimus Levels and Clinical Response After Adjunct Therapy With Cutaneous Application of Tacrolimus 0.1% Over Upper Eyelid Skin in Chronic Vernal Keratoconjunctivitis.

The aim of this study was to evaluate the role of cutaneous application of 0.1% tacrolimus eye ointment over the skin of the upper eyelid in chronic vernal keratoconjunctivitis (VKC). A prospective, longitudinal, noncomparative, open-label clinical study of moderate-to-severe grade steroid-dependent VKC was performed. Study participants were initiated on adjunct therapy of cutaneous application of 0.1% tacrolimus ointment twice daily on the upper eyelid skin. Ocular surface evaluation parameters, meibomian gland imaging, intraocular pressure, visual acuity, and clinical disease severity scoring were performed to assess clinical response at baseline and month 3 of therapy. Tear levels of tacrolimus were measured at month 3 using high-performance liquid chromatography tandem mass spectrometry and correlated with the clinical score. Palpebral form of VKC was observed in 85% of the cases, with positive family history in 5%, atopy in 7.5%, and keratoconus in 11.25%. Clinical assessment revealed improvement in 97.5% patients with discontinuation of concomitant topical steroids in 64% of patients. There were no changes in visual acuity, intraocular pressure, or ocular surface evaluation after therapy. Tacrolimus was detected in the tears of all our study patients after cutaneous application over the upper eyelid skin, proving its bioavailability with mean tear tacrolimus levels of 6.55 ± 21.43 ng/mL. Correlation analysis revealed a moderate negative correlation between the clinical score and tacrolimus concentration (Spearman correlation coefficient: -0.34, P = 0.002). Cutaneous tacrolimus 0.1% ointment over the upper eyelid skin is an efficacious alternative method of application in treatment of VKC, with no resultant ocular irritation.

Anterior-segment optical coherence tomography for tacrolimus therapy response monitoring of vernal keratoconjunctivitis

Background: Vernal keratoconjunctivitis (VKC), a chronic bilateral eye disease, is a severe form of allergic conjunctivitis. Anterior-segment optical coherence tomography (AS-OCT) is a rapid, noninvasive, in vivo visualization modality for the anterior segment structures that has been used in diagnosing and staging diseases and assessing the treatment efficacy. We used anterior-segment optical coherence tomography (AS-OCT) to monitor the efficacy of the tacrolimus eye ointment in managing VKC.
 Methods: In this prospective follow-up study, we included patients with active symptomatic VKC. All patients were treated with the 0.03% tacrolimus ophthalmic ointment twice daily for 2 months and then once daily for 1 month. All patients underwent AS-OCT before and 3 months after treatment as an objective method to assess the treatment efficacy.
 Results: We included 20 eyes of ten patients (nine men and one woman) with active symptomatic VKC. The mean age was 17.3 (range: 11 – 36) years, with nine patients having a palpebral type and one patient having a mixed type of VKC. Substantial flattening and reduction in the papilla size were observed in all patients at the post-treatment follow-up. AS-OCT measurements revealed significant reductions in the vertical, horizontal, and total diameters of the palpebral papillae and limbal conjunctival thickness after 3 months of treatment compared to baseline measurements (all P < 0.001). No serious adverse effects attributable to tacrolimus administration were observed in the study period.
 Conclusions: AS-OCT is a suitable objective method for evaluating the treatment efficacy of the 0.03% tacrolimus eye ointment in patients with VKC. Future large-scale studies including a wide range of age groups with longer follow-up periods and AS-OCT monitoring at multiple post-treatment visits are required to confirm our preliminary results. Moreover, the diagnostic accuracy of AS-OCT in monitoring patients with active VKC should be tested in comparison with objective scoring by an experienced corneal fellowship.

Evaluation of tacrolimus and cyclosporine in the treatment of vernal keratoconjunctivitis in children

Aims: To compare the efficacy and safety of 0.03% tacrolimus eye ointment with 2% cyclosporine eye drops in the treatment of vernal keratoconjunctivitis. Settings and Design: Comparative, Hospital-based, Prospective, Randomized, Clinical study. Methods and Material: About 56 children diagnosed with Vernal keratoconjunctivitis (VKC) were enrolled in the study. All the subjects underwent a comprehensive ophthalmic evaluation. Total subjective symptom scoring (TSSS) and Total objective sign scoring (TOSS) were done for each patient based on their history and clinical examination. They were divided into two groups. One group was treated with 0.03% tacrolimus ointment bd and the other with 2% cyclosporine eye drops tid. Both groups were also put on carboxymethylcellulose eye drops four times a day. Steroids were never used during the study. The patients were followed up at intervals of two weeks, four weeks, and eight weeks. At each follow-up, the TSSS and TOSS were done for each patient. Patients were also questioned about any adverse effects encountered by them during the treatment. A comparison was done between both groups based on the above scoring. Results: There was progressive reduction which was statistically significant (P < 0.05) in the TSSS and TOSS in both the groups throughout treatment. Reduction in TSSS The only adverse effect reported by a few patients was a burning sensation that was not severe enough to discontinue treatment. Conclusions: Both tacrolimus 0.03% eye ointment and cyclosporine 2% eye drops are effective in the treatment of VKC without any significant severe side effects. Tacrolimus eye ointment was more effective than cyclosporine drops.

TO COMPARE THE EFFICACY OF TACROLIMUS (0.1%) Vs CYCLOSPORINE (0.05%) IN VERNAL KERATO-CONJUNCTIVITIS (VKC)

Introduction- The aim of the study was to evaluate and compare the efcacy and safety of topical Tacrolimus (0.1%) as compared to topical Cyclosporine (0.05%) in treatment of vernal keratoconjunctivitis patients. Methodology- A Prospective, comparative, interventional study was conducted in 142 patients of VKC between February 2020 to august 2021 attending the ophthalmic outpatient department of our hospital. Patients were screened for inclusion and exclusion criteria and included in the study after obtaining informed, written consent from the patients or their guardian. Right eye was be treated with Cyclosporine (0.05%) eye drop th th th twice daily and the left eye was treated with Tacrolimus (0.1%) eye ointment twice daily for 2 months. Patients were followed up on 15 , 30 , 60 st day on medication. Then the treatment was withdrawn and patients were reviewed after 4 weeks. At each follow up and at 1 visit patients symptoms were graded, recorded and compared as Total Subjective Symptoms Score (TSSS) and Total Objective ocular sign Score (TOSS). Result -Both TOSS and TSSS decreased in both the eye consistently without any effect on Intra-ocular pressure. Improvement in scores was more in left eye. But scores increased after the withdrawal of drug, still lower than baseline scores. Conclusion - Disease has greater propensity in males. Both the drugs were found to be effective and safe, but 0.1% Tacrolimus eye ointment found to be superior than 0.05% Cyclosporine eye drop. Only side effect with tacrolimus eye ointment was stinging sensation on instillation of drug.

A comparative study between ciclosporine A eye drop (2%) and tacrolimus eye ointment (0.03%) in management of children with refractory vernal keratoconjunctivitis.

To compare the effects of ciclosporine A (2%) eye drop and tacrolimus (0.03%) eye ointment on children with vernal keratoconjunctivitis (VKC) who were not responding to corticosteroid eye drops. A prospective comparative study was carried out on children who were diagnosed with refractory VKC at the ophthalmology clinic in Benha University, Delta area, Egypt, during the period from October 2019 to February 2020. Fifty-nine patients completed this study. Regarding the individual symptom score, redness, burning, photophobia, and foreign body sensation were significantly reduced in the tacrolimus group compared to those in the ciclosporine A group during the 1st week (p < 0.05). Moreover, the tacrolimus group showed a statistically significant reduction in burning and foreign body sensation at the 4th week (both p = 0.032), and in redness and burning sensation at the 12th week compared to those in the ciclosporine A group (p = 0.005 and 0.048, respectively). The tacrolimus group showed significantly lower mean scores for tarsal conjunctival papillary hypertrophy at the 1st week and 12th week (p = 0.037 and 0.046, respectively), and for punctate erosion and cobblestone papillae at the 1st week (p = 0.029 and 0.037, respectively) than the ciclosporine group. Failure of treatment was observed in 6 patients (19.35%) in the ciclosporine A group and in 5 patients (17.85%) in the tacrolimus group. No serious side effects were detected in any group. A higher reduction in inflammatory symptoms and signs as well as compliance with tacrolimus 0.03% eye ointment than with ciclosporine A 2% eye drops was observed. Moreover, long-term medication for refractory cases is needed to control inflammation. Overall, our finding suggested that ciclosporine A eye drops and tacrolimus eye ointment could be considered as corticosteroid-sparing drugs in the management of children with refractory VKC.

Is Interferon α-2b 1 MillionIU/mL Truly Better Than Tacrolimus 0.03% for Steroid-Resistant VKC ?: Our 2-Year Experience at a Tertiary Health-Care Centre.

PurposeTo compare the efficacy of eye-drop interferon (IFN) α-2b 1 millionIU/mL with eye-ointment tacrolimus 0.03% in refractory vernal keratoconjunctivitis (VKC).Materials and MethodsFifty patients with VKC refractory to conventional treatment with topical corticosteroids and antihistamines after 4 weeks of regular use were selected retrospectively. Patients were divided into two groups depending on whether they received eye-ointment tacrolimus 0.03% three times a day or eye-drop IFN alpha-2b 1 millionIU/mL three times a day and were followed up for 24 months. The main outcome measures were total subjective symptom score (TSSS) and total objective ocular score (TOSS).ResultsMean baseline TSSS was 7.24±1.98 in Group A (tacrolimus group) and 7.84±1.82 in Group B (IFN group), and it reduced to 1.12±0.83 in Group A and 0.62±0.41 in Group B at 6 months, which was statistically significant compared to the baseline score (p<0.05) as well as between the two groups. Mean baseline TOSS was 6.72±2.07 in Group A and 6.56±2.04 in Group B, and it improved to 1 month onwards to 1.52±0.87 in Group A and 1.0±0.71 in Group B at 6 months, which was statistically significant compared to the baseline score (p<0.05) as well as between the two groups. Side effects like stinging and burning sensations were seen in the tacrolimus group only.ConclusionOur study suggests that while both eye-drop IFN α-2b 1 millionIU/mL and eye-ointment tacrolimus eye ointment 0.03% are both safe and effective steroid-sparing agents in steroid-resistant VKC. IFN α-2b results in greater improvement in subjective symptoms and objective signs, has fewer side effects in long term and is better tolerated as compared to tacrolimus.

A comparative study of efficacy, tolerability and safety of 0.03% tacrolimus eye ointment and 0.05% cyclosporin eye drops in the treatment of vernal keratoconjunctivitis

Background: Vernal keratoconjunctivitis (VKC) is a common, chronic, bilateral, recurrent, allergic, inflammatory disease of the ocular surface primarily affecting young males in dry, hot climates such as India.Objectives: To compare the efficacy, tolerability and safety of 0.03% tacrolimus eye ointment and 0.05% cyclosporin eye drops in the treatment of vernal keratoconjunctivitis. Methods: A prospective study of 72 patients conducted from December 2017 to February 2021. After having established a diagnosis of VKC and fulfilling inclusion and exclusion criteria, participants were divided into two groups. Group 1 was put on cyclosporin eye drops and group 2 was put on tacrolimus eye ointment. Detailed history and evaluation for symptoms, signs, visual acuity and IOP was done on first visit and subsequently after 6 weeks, 12 weeks and 24 weeks. Results: 72 patients were diagnosed to have VKC, of whom males were 86% and females 13.9%, all belonging to the age group 5 to 14 years and were divided into two groups. Both the groups showed significant reduction in the symptoms and signs with no significant difference in efficacy between the groups and they maintained normal IOP and visual acuity at 6 weeks, 12 weeks and 24 weeks.Conclusion: Both the immunomodulators were equally successful in resolving the signs and symptoms of VKC, tolerable with no significant adverse effects and proved to be a safer alternative to steroids as they caused no elevation of intraocular pressure or any complications associated with the use of steroids.

Use of tacrolimus ointment (0.03%) for refractory VKC

We report a series of 8 children with severe vernal keratoconjunctivitis who presented to us over last two years. The mean age was 7.375 years. The mean vision was 0.375 OD and 0.3625 OS. All these children were using topical steroids of varying strengths for more than two year. 2 out of 8 children had secondary glaucoma. The mean intraocular pressure was 21.75 + 4.74 OD and 23.25 + 6.25 mm of Hg OS. The highest IOP recorded was 28 mm Hg. All patients with glaucoma had early optic disc changes. Topical steroids were stopped for all patients and they were started on topical tacrolimus eye ointment (0.03%) twice a day along with lubricants. Patients relative were counseled to avoid eye rubbing, ignore minimal redness of eyes and counseled against any form of steroids. All patients continued tacrolimus for 3 months. Tacrolimus ointment was stopped at 3 month and lubricants were continued. Follow up was done at 1st week, 3rd week, 6th week, 3rd month and monthly thereafter till 6 months. At 6 months follow up all except one patient was discontinued of antiglaucoma medication. Keywords: VKC, Tacrolimus.

A study on the use of tacrolimus eye oitment (0.03%) in allergic eye disease

Aim: To study the effect of 0.03% tacrolimus eye ointment in allergic eye disease Materials and Methods: This prospective study was conducted on patients suffering from recurrent allergic eye disease. All those patients who used steroids frequently because of recurrence or chronic refractory cases were included in this study. We included 48 cases in this study. Tacrolimus 0.03% eye ointment was used twice daily for 3 months and effect was seen in terms of improvement in symptoms, signs and any recurrence if occurred after stopping treatment. Results: Mean age of the patient was 21.04 7.02 and mean duration of allergic eye disease was 3.52 0.94. Symptoms and sign scores shown improvement after using tacrolimus eye ointment for 3 months. Itching and redness (88% & 82% respectively) improved dramatically at the end of 1 month. Recurrence was noticed at 6th month follow up in 6 cases after stopping tacrolimus eye ointment so it was restarted. While in 42 cases (87.5%) we didn’t notice any recurrence after stopping tacrolimus eye ointment. Conclusion: Tacrolimus eye ointment (0.03%) is effective in controlling allergic eye disease and is very effective steroid sparing drug in chronic recurrent cases where frequent use of steroids is required. Keywords: Allergic eye disease, Vernal keratoconjunctivitis, Perennial allergic conjunctivitis, Immunomodulators & mast cell stabilizers.

Comparative analysis of efficacy and adverse effects of tacrolimus vs cyclosporine in chronic dry eye disease: a tertiary care hospital based study

Background: Dry eye disease (DED) is the very common and underdiagnosed ocular condition affecting vision, quality of life, and the outcomes of cataract or refractive surgery. Dry eye disease (DED), either alone or in combination with other conditions, is a frequent cause of ocular irritation that leads the patients to seek ophthalmic care. Due to a wide variety of presenting symptoms, it is often unrecognized and this causes great frustration of the patient and treating physician. While these symptoms often improve with appropriate treatment, usually in majority of the cases the disease may not be curable. Aim of the study was to compare the efficacy of tacrolimus and cyclosporine in dry eye disease.Methods: This was a single centred, 3 months prospective study. Patients with unilateral or bilateral dry eye disease and an ocular surface disease index score &gt;12, atleast one eye with schirmer score &lt;5mm and TBUT &lt;10 s were enrolled in the study. The enrolled patients were randomly divided into two groups, twenty-five patients in Group 1 and twenty three patients in Group 2 completed the follow up. Group 1(n =25) who received 0.03% tacrolimus eye ointment twice daily for consecutive 3 months and Group 2 (n= 23) received 0.05% cyclosporine eye drops twice daily for consecutive 3 months the primary efficacy outcome was Schirmer score after 3 months. The secondary outcomes were TBUT and adverse effects.Results: After 3 months, both the treatment groups showed significant improvement in mean Schirmer score (p&lt;0.001) and mean TBUT (p &lt;0.0001). However, on comparing both the groups, mean Schirmer score and mean TBUT, results were comparable. No patient discontinued treatment because of minor ocular adverse effects.Conclusions: Dry eye patients demonstrated improvement in Schirmer score and TBUT after 3 months of treatment with tacrolimus 0.03% ointment and cyclosporine 0.05% eye drops.

Tacrolimus in Corticosteroid-Refractory Vernal Keratoconjunctivitis.

To evaluate the efficacy of 0.03% tacrolimus in the treatment of corticosteroid-refractory vernal keratoconjunctivitis (VKC). This open-label study enrolled 30 patients with VKC who were not responding to topical corticosteroid treatment for at least 4 weeks. All patients were treated with 0.03% tacrolimus eye ointment 3 times daily, 0.05% ketotifen eye drops twice daily, and preservative-free artificial tears. Symptoms (itching, redness, watering, discharge, burning, and photophobia) and signs (conjunctival injection, papillae, cobblestone papillae, limbal inflammation, or hypertrophy and corneal epithelial staining) were graded on a 4-point scale at enrolment, after 4 weeks, and at the end of treatment period, which was at 12 weeks. Composite scores for symptoms and signs were computed by summing individual scores. Treatment failure was denoted if additional treatment with corticosteroids were required. The composite scores for symptoms (10.8, 3.8, 3.4) and signs (8.7, 4.7, 4.0) in 23 patients showed a statistically significant (P < 0.05) improvement from baseline to the 4- and 12-week visits. Among the signs, upper tarsal papilla showed improvement only at 12 weeks, but the scores for giant cobblestone papillae did not reach statistically significant reduction even at 12 weeks. There was improvement in visual acuity at 12 weeks, although it was not statistically significant (P = 0.05). Treatment failure was recorded in 17% patients. The only adverse effect reported was transient stinging sensation lasting for a few days. Tacrolimus 0.03% was apparently safe and effective in treating patients with steroid-refractory VKC. A small subset of patients may still require supplemental topical corticosteroids for resolution of their symptoms.

Therapeutic effect of 0.1% Tacrolimus Eye Ointment in Allergic Ocular Diseases.

Allergic Ocular Diseases (AODs) like Atopic Keratoconjunctivitis (AKC) and Vernal Keratoconjunctivitis (VKC) are chronic forms of ocular allergy that can cause severe visual complications. Pathogenesis of AODs is uncertain and treatment has been a challenge for ophthalmologists. Tacrolimus, a 23-member cyclic macrolide lactone derived from [streptomyces tsukubaensis] now in ointment form has been successfully used in AODs. To study the therapeutic effect of 0.1% Tacrolimus eye ointment in patients with Allergic Ocular Diseases (AODs). This prospective observational study was conducted on 36 patients with severe AOD and moderate cases not responding to conventional treatment. They were treated with 0.1% tacrolimus eye ointment twice daily for minimum three months in addition to conventional treatment and observed for a period of 6 months. Symptoms and signs after treatment were evaluated. Grades of clinical signs were assessed based on slit lamp clinical photographs; development of possible complications was assessed and analysed by Wilcoxon signed rank test. Mean age of patients was 9.3±4.3 years and mean duration of AODs was 3.1±1.8 years. The scores on both the four point scales for signs and symptoms decreased significantly (p<0.0001) after 1 month of 0.1% Tacrolimus eye ointment treatment. Itching was the first symptom to show dramatic relief and conjunctival hyperaemia was the first sign to show improvement. 88.88% of patients were successfully weaned off topical steroids in 6 months into Tacrolimus treatment. Even in patients unresponsive to 0.1% topical Cyclosporine, symptoms and signs scores decreased significantly (p<0.0001). The most common adverse reaction was a transient burning sensation (36.11%). Topical 0.1% Tacrolimus eye ointment was found to be a safe and effective treatment in cases of AODs and also worked as steroid sparing and replacing agent. It was also found effective in patient's refractory to topical Cyclosporine.

Therapeutic effects of tacrolimus eye ointment in refractory allergic conjunctivitis

The objective of this study was to investigate the efficacy of topical 0.1% tacrolimus and 0.03% tacrolimus eye ointment in treating refractory allergic conjunctivitis. This prospective observational study included 30 patients with refractory allergic conjunctivitis whose condition had responded poorly to conventional anti-allergic drugs and/or topical steroids and/or topical cyclosporine. All patients received tacrolimus eye ointment twice daily during the study period. Ten clinical signs and six clinical symptoms were rated on a four-grade scale. The primary endpoint was the change from baseline in total clinical signs and symptoms score at the last observation or following 6 months of treatment. Total signs and symptoms score significantly decreased after 1 month of treatment (p<0.001). Giant Papillae were also reduced by tacrolimus eye ointment use (p<0.001). The drug proved effective in patients whose condition did not respond well to topical cyclosporine. The most common adverse reaction was a transient burning sensation (3.20%). Tacrolimus ointment 0.1% is more effective than 0.03% in treating refractory allergic conjunctivitis and may reduce or replace topical steroid use

Effect of Topical Tacrolimus in the Treatment of Thygeson's Superficial Punctate Keratitis

To evaluate topical tacrolimus ointment for treating Thygeson's superficial punctate keratitis (Thygeson SPK). Retrospective interventional case series. setting: Institutional practice. The medical records of 14 patients (9 women; age range, 9-65 years) with Thygeson SPK were reviewed retrospectively. Diagnosis was based on the history and clinical examination. Patients were treated with tacrolimus 0.03% eye ointment instilled into the lower fornix twice daily for the first 2 weeks, followed by nocturnal application. The clinical signs and symptoms were assessed after 1 month of treatment. The drug was tapered with disease improvement. Treatment efficacy and side effects. All patients had bilateral disease (average duration, 6 years). All patients, except 2 who used the medication irregularly, had improved visual acuity (VA), symptoms, and signs as long as the medication was applied. Before treatment 28.57% of patients had VA between 20/30 and 20/50, with improvement after treatment to 20/25 or 20/20. Attempts to withdraw the medication resulted in recurrent disease, and, therefore, treatment was not curative during the study period. No significant local medication side effects were reported. Tacrolimus eye ointment 0.03% was effective for controlling Thygeson SPK for a long period with good patient tolerance and no noticeable local or systemic side effects. During the average 6-year follow-up, treatment was not curative. Randomized studies are difficult to conduct because of the disease rarity.

Efficacy of topical application of 0.03% tacrolimus eye ointment in the management of allergic conjunctivitis.

Background:Allergic conjunctivitis is commonly observed eye diseases in Sikkim, India due to the abundance of seasonal pollens, environmental pollutants, and house dust. We evaluated the efficacy of topical 0.03% tacrolimus eye ointment in the management of simple allergic conjunctivitis.Materials and Methods:A prospective observational study was designed consisting of 41 patients with refractory simple allergic conjunctivitis, whose condition responded very poorly to conventional anti-allergic eye drops (azelastine, olopatadine, chlorpheniramine maleate, sodium chromoglycate). Simple allergic conjunctivitis cases were diagnosed and followed up evaluating both subjective and objective findings (itching, photophobia, tearing, chemosis, conjunctival congestion, tarsal papilla, and eyelid edema). Existing ocular treatment was discontinued at enrolment and 0.03% tacrolimus ointment was applied into the conjunctival sac of the affected eyes twice daily for 4 weeks followed by a 2 weeks washout period. Patients were followed up at the end of 1st week, 4th week, and at 7th week (2 weeks washout period).Results:Symptoms of simple allergic conjunctivitis (itching, tearing and photophobia) were significantly reduced at the end of 1st week. Signs such as conjunctival chemosis, congestion, tarsal papillae, and eyelid edema were effectively treated in all cases at the end of 1st week. At the end of 4th week, all cases were fully cured and none of the patient had any recurrences up to 7th week. Mean score at 1st day (9.6 ± 3.27) was significantly (P < 0.0001) reduced by 7th day (1.35 ± 1.19) of treatment.Conclusion:Topical application of tacrolimus ointment is an excellent alternative to anti-allergic and steroids eye drops for the treatment of simple allergic conjunctivitis as it significantly reduces recurrences.