Dry Eye Research Articles

Emerging Ocular Side Effects of Immune Checkpoint Inhibitors: A Comprehensive Review

Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, offering significant improvements in patient survival across various malignancies. However, their use is associated with a broad spectrum of immune-related adverse events (irAEs), including those affecting the eye and its surrounding structures, collectively termed ocular irAEs (OirAEs). Although rare, OirAEs (e.g., keratitis, uveitis, retinal vasculitis, etc.) can significantly impact a patient’s quality of life, leading to ocular complications if left untreated. This review provides a comprehensive overview of OirAEs associated with ICIs, including their clinical manifestations, underlying mechanisms, and current management strategies. We delve into the anterior and posterior segment adverse events, highlighting conditions such as dry eye, uveitis, and retinal disorders, as well as neuro-ophthalmic and orbital complications. Furthermore, we discuss the challenges in diagnosing and treating these conditions, particularly given the overlap with other autoimmune and paraneoplastic syndromes. Finally, we identify key knowledge gaps and suggest future research directions aimed at optimizing the management of OirAEs while maintaining the efficacy of cancer therapy. This review underscores the need for increased awareness among clinicians to prevent irreversible ocular damage and enhance patient outcomes.

Advanced Biomaterials for Lacrimal Tissue Engineering: A Review

The lacrimal gland (LG) is vital for ocular health, producing tears that lubricate and protect the eye. Dysfunction of the LG leads to aqueous-deficient dry eye disease (DED), significantly impacting quality of life. Current treatments mainly address symptoms rather than the underlying LG dysfunction, highlighting the need for regenerative therapies. Tissue engineering offers a promising solution, with biomaterials playing crucial roles in scaffolding and supporting cell growth for LG regeneration. This review focuses on recent advances in biomaterials used for tissue engineering of the lacrimal gland. We discuss both natural and synthetic biomaterials that mimic the extracellular matrix and provide structural support for cell proliferation and differentiation. Natural biomaterials, such as Matrigel, decellularized extracellular matrices, chitosan, silk fibroin hydrogels, and human amniotic membrane are evaluated for their biocompatibility and ability to support lacrimal gland cells. Synthetic biomaterials, like polyethersulfone, polyesters, and biodegradable polymers (PLLA and PLGA), are assessed for their mechanical properties and potential to create scaffolds that replicate the complex architecture of the LG. We also explore the integration of growth factors and stem cells with these biomaterials to enhance tissue regeneration. Challenges such as achieving proper vascularization, innervation, and long-term functionality of engineered tissues are discussed. Advances in 3D bioprinting and scaffold fabrication techniques are highlighted as promising avenues to overcome current limitations.

Combining the Strengths of MS and NMR in Biochemometrics: A Case Study on Buddleja officinalis.

Biochemometrics has emerged as promising strategy for the targeted identification of bioactive constituents from natural sources. It is based on the correlation of bioactivity data with chemical data to reveal constituents contributing to activity. Providing complementary data and structural information, MS- and NMR-based biochemometric approaches have both been separately applied in the past. The herein presented study is dedicated to the evaluation of a combined MS- and NMR-based biochemometric workflow for the unambiguous identification of bioactives. As an example, a flower extract of Buddleja officinalis Maxim. was selected to unravel bioactive constituents in the context of dry eye disease pathology. While NMR-based biochemometrics relies on heterocovariance analysis (HetCA) of 1H NMR spectra using the previously established ELINA approach, a biochemometric molecular network was generated for the MS-based approach. Both analyses were performed in parallel and were ultimately combined to increase their power to identify the bioactive constituents from the complex mixture. As a result, phenylethanoid glycosides and triterpene saponins were discovered as main contributors for the antioxidant and cytotoxic effects of the extract. This article illustrates the advantages, opportunities, and limitations of MS and NMR in the context of biochemometrics.

Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials

BackgroundDry eye disease (DED) is commonly caused by excessive tear film evaporation due to Meibomian gland dysfunction (MGD). There is a need for DED treatment options that address tear evaporation and benefit patients across a broad range of demographic and disease characteristics. This study evaluated treatment effects of perfluorohexyloctane ophthalmic drop (formerly NOV03) in the pooled dataset from 2 pivotal clinical trials in patients with DED associated with MGD, both in the overall population and in patient subgroups based on sex, age, and baseline severity of eye dryness.MethodsPooled data from 2 similarly designed, phase 3, randomized controlled trials (GOBI, MOJAVE) were analyzed. Patients aged ≥18 years with DED administered perfluorohexyloctane (n=614) or hypotonic (0.6% solution) saline control (n=603) four times daily for 8 weeks. Primary endpoints were total corneal fluorescein staining (tCFS) score (National Eye Institute scale, 0-15) and eye dryness visual analog scale (VAS) score (0-100). Efficacy was evaluated using analysis of covariance among patient subgroups (male and female, older [≥65 years] and younger [18 to <65 years], tCFS score <7 and ≥7, VAS eye dryness score <70 and ≥70, MGD score <7 and ≥7, Schirmer I test <10 mm and ≥10 mm).ResultsReductions in tCFS and VAS eye dryness scores were greater for perfluorohexyloctane versus control. In the overall patient population, least-squares mean treatment difference was −1.1 (95% CI: −1.41 to −0.79; p<0.0001) for tCFS and −9.0 (95% CI: −11.90 to −6.00; p<0.0001) for VAS eye dryness. Treatment favored perfluorohexyloctane over control in all patient subgroup analyses of tCFS and VAS eye dryness. Overall, the most common adverse event with perfluorohexyloctane was blurred vision (2.1% of patients), which was mild and transient.ConclusionsCompared with a hypotonic saline control, perfluorohexyloctane improved both the signs and symptoms of DED, including in patients with greater self-reported severity of eye dryness.Clinical trial registrationThis study represents an integrated analysis of 2 previous clinical trials: GOBI (ClinicalTrials.gov, NCT04139798) and MOJAVE (ClinicalTrials.gov, NCT04567329).

Spotlight on Amniotic Membrane Extract Eye Drops: A Review of the Literature.

To review the literature focusing on the effectiveness of amniotic membrane extract eye drops (AMEDs) in the treatment of ocular surface diseases. PubMed/MEDLINE, Scopus, and CENTRAL databases were searched until March 4, 2024. Overall, we identified 1,121 studies, 26 of which were selected for a full-text review. Twelve studies met the inclusion criteria and were analyzed for clinical improvements, time to resolution of corneal staining, adverse events, and preparation methods. Strength of clinical data was graded according to the Oxford Center for Evidence-Based Medicine. Overall, AMED compounds were used in 296 eyes of 205 patients. Fifty-nine percent of eyes were treated for dry eye disease, 23% for an epithelial defect, and the rest (18%) for other corneal wound healing disorders. Three main types of eye drops preparation were described, that is, lyophilized, homogenized, and fresh AMED. Although the methods of outcome reporting were heterogeneous, all included studies showed various grades of improvement in both signs and symptoms. The overall incidence of ocular side effects was 2.3%. Despite the suboptimal quality of evidence, overall, the available literature suggests that AMED is a valuable tool in the treatment of ocular surface disorders.

Short-term variability in ocular biometry and the impact of preoperative dry eye.

This study aimed to investigate the short-term variability of ocular biometric measurements and to analyze the factors associated with high variability of biometric values in patients with cataract. This retrospective study included 60 eyes of 60 patients who underwent ocular biometry twice with the IOLMaster 700 (March to November 2023). Ocular surface parameters included tear film break-up time (TBUT), corneal and conjunctival staining scores (CSS/ConSS). Refractive surprise was defined as a mean absolute error exceeding 0.5 diopter (D). Participants included 22 men and 38 women with a mean age of 70.6 ± 8.4 years. The variability of mean keratometric (K) values and astigmatism showed notable variability compared to axial length (mean K: 0.18 ± 0.17D, astigmatism: 0.21 ± 0.26D, axial length: 0.01 ± 0.01mm). A decreased TBUT and increased CSS were significantly associated with high variability (≥ 0.25D) of mean K (p = 0.040/0.008). The high K variability group (≥ 0.25D) revealed a significantly higher incidence of refractive surprise (> 0.5D) compared with the low K variability group (< 0.25D) (45.5%/17.9%, p = 0.037). Preoperative lower TBUT and higher CSS influenced the variability of K values in ocular biometry and may be related with postoperative refractive surprise due to erroneous K values.

PINK1/Parkin-Mediated Mitophagy Ameliorates Mitochondrial Dysfunction in Lacrimal Gland Acinar Cells During Aging.

Aging alters the function of the lacrimal gland and disrupts the balance of the microenvironment on the ocular surface, eventually leading to aqueous-tear-deficient dry eye. Mitophagy has been reported to play an important role in aging, but the underlying mechanism remains unclear. The young (6 weeks) and middle-aged (12months) male C57BL/6J mice were used in this study, and mitophagy agonist rapamycin and inhibitor Mdivi-1 were used in in vivo experiments. Hematoxylin and eosin, Masson, Oil Red O, and reactive oxygen species (ROS) staining were used to detect histological changes and lipids in lacrimal gland. Changes in the expression of proteins were identified by Western blotting of lacrimal gland lysates. Transmission electron microscopy and immunofluorescence staining were used to assess mitophagy. The single-cell RNA sequencing (scRNA-seq) and bioinformatics analyses were used to detect transcription signature changes during aging. In this study, we discovered that aging increased oxidative stress, which increased apoptosis, and generated ROS in acinar epithelial cells. Furthermore, activation of PINK1/Parkin-mediated mitophagy by rapamycin reduced lacrimal gland ROS concentrations and prevented aging-induced apoptosis of acinar cells, thereby causing histological alterations, microstructural degradation, and increasing tear secretion associated with ROS accumulation. By contrast, Mdivi-1 aggregates mitochondrial function and thereafter leads to lacrimal gland function impairment by inhibiting mitochondrial fission and giving rise to mitophagy. Overall, our findings suggested that aging could impair mitochondrial function of acinar cells, and age-related alterations may be treated with therapeutic approaches that enhance mitophagy while maintaining mitochondrial function.

The Effect of Polyunsaturated Fatty Acid (PUFA) Supplementation on Clinical Manifestations and Inflammatory Parameters in Individuals with Sjögren’s Syndrome: A Literature Review of Randomized Controlled Clinical Trials

Background. Sjögren’s syndrome is a chronic autoimmune disease that causes dry mouth and eyes and can lead to non-Hodgkin’s lymphoma in 5–10% of cases after 10 years. Clinical trials have shown that the oral administration of polyunsaturated fatty acids (PUFAs) seems to have a beneficial effect on Sjögren’s syndrome. Aim. This literature review provides an overview of the effects of PUFA supplementation on clinical manifestations and inflammatory parameters in Sjögren’s syndrome. Methodology. We conducted a literature review using the PubMed, Biomed Central, and Cochrane Library electronic databases and using search terms “Sjögren” AND “omega-3”; and “omega-6” AND “fatty acids” AND “oil”. This literature review followed the PRISMA guidelines and included randomized clinical trials in humans with or without a control group using the oral administration of PUFA. Results. From 26 articles found in the databases, a total of 6 articles were included. Of these six trials, five trials showed an effect on clinical manifestations and three trials on inflammatory parameters. Most of the studies did not show a significant effect on the parameters analyzed. One study showed a significant improvement in dry keratoconjunctivitis compared to the control group. The results suggest that PUFAs may improve inflammatory parameters in patients with Sjögren’s syndrome. Conclusions. This literature review supports the idea that the oral administration of PUFA may possess a potential effect on clinical manifestations. However, due to the limited number of studies and the heterogeneity of clinical trial methodology, further investigations should be employed. Understanding the potential mechanism of action of PUFAs on clinical biomarkers in Sjögren’s syndrome may clarify their importance in clinical practice for health professionals.

In vivo lacrimal gland imaging artefact assessment based on swept-source optical coherence tomography for dry eye disease.

This study aimed to characterise imaging artefacts in the lacrimal gland using swept-source optical coherence tomography (SS-OCT) in patients with dry eye disease (DED) and healthy participants and identify risk factors for these artefacts. In total, 151 eyes, including 104 from patients with DED and 47 from non-DED participants, were analysed. Demographic data collection, comprehensive ocular examinations and SS-OCT imaging of the palpebral lobe of the lacrimal gland were performed. Artefacts were classified into distinct categories with different severities. Univariate and multivariate logistic regression analyses were performed to evaluate the association of age, gender, best-corrected visual acuity, intraocular pressure (IOP) and the presence of DED with the presence of artefacts. Eight artefact types and severity grading were defined by analysing 1208 lacrimal SS-OCT images. The three most prevalent artefacts were defocus (75.83%), cliff (67.47%) and Z-off (58.44%). The presence of artefacts was significantly associated with the presence of DED (OR=9.13; 95% CI, 2.39 to 34.88; p=0.001) and higher IOP (OR=1.34; 95% CI, 1.14 to 1.58; p<0.001). Furthermore, multivariate logistic analyses showed that lower tear film breakup time (OR=0.71; 95% CI, 0.55 to 0.92; p=0.009) and higher meibum quality score (OR=2.86; 95% CI, 1.49 to 5.48; p=0.002) were significantly associated with higher odds for the presence of artefacts. DED eyes had more SS-OCT image artefacts than normal eyes. Stringent standardised image quality control should be implemented before further image analysis when using SS-OCT to assess lacrimal gland image.

Phospholipid Nanoemulsion-Based Ocular Lubricant for the Treatment of Dry Eye Subtypes: A Multicenter and Prospective Study.

Dry eye disease (DED) is a multifactorial condition of the ocular surface (OS) characterized by loss of tear film homeostasis, ocular discomfort, and vision disturbances. Most available ocular lubricants target the aqueous deficiency of the tear, restoring only this layer, leaving the tear lipid stratum deficient, as occurs in most patients with evaporative DED. An innovative propylene glycol-hydroxypropyl guar enriched with a phospholipid nanoemulsion (PG-HPG-PH-N) is indicated to restore deficiencies in both the lipid and aqueous layers of the tear film, and its composition was designed to increase lubricant retention on the OS. The purpose of this study was to evaluate, through the Ocular Surface Disease Index (OSDI) and clinical assessment, the treatment of patients who had DED due to aqueous deficiency arising from mixed or evaporative DED subtypes with a PG-HPG-PH-N ocular lubricant at a reduced frequency of twice a day, in a prospective, multicenter, and single-arm study. Patients were screened from days - 7 to 0, and from day 1 (baseline and first day of treatment) to day 28 of treatment with this lubricant. After visit 1 (screening visit, days - 7 to 0), designed as pre-treatment OS assessment, patients returned to their research center on days 14 and 28 of treatment for a complete assessment, including anamnesis, the OSDI, corrected visual acuity, tear breakup time (TFBUT), OS staining evaluation, tolerability index, and environmental exposure questionnaire. Seventy patients were enrolled in this study (60 women, 10 men), with a mean age of 45 (range 27-64) years. TFBUT results showed an improvement in tear film stability as vital dyes sodium fluorescein and lysamine green showed a decrease in corneal staining after 14 and 28days of treatment. No significant adverse events were reported, demonstrating the good tolerability of the lubricant. The PG-HPG-PH-N nanoemulsion can be considered to be a safe and effective ocular lubricant for treating DED due to aqueous deficiency, both mixed and evaporative subtypes. Brazilian National Research Ethics Commission (ReBEC registration number 16055).

Developments in Emerging Topical Drug Delivery Systems for Ocular Disorders.

According to the current information, using nano gels in the eyes have therapeutic benefits. Industry growth in the pharmaceutical and healthcare sectors has been filled by nanotechnology. Traditional ocular preparations have a short retention duration and restricted drug bioavailability because of the eye's architectural and physiological barriers, a big issue for physicians, patients, and chemists. In contrast, nano gels can encapsulate drugs within threedimensional cross-linked polymeric networks. Because of their distinctive structural designs and preparation methods, they can deliver loaded medications in a controlled and sustained manner, enhancing patient compliance and therapeutic efficacy. Due to their excellent drugloading capacity and biocompatibility, nano-gels outperform other nano-carriers. This study focuses on using nano gels to treat eye diseases and provides a brief overview of their creation and response to stimuli. Our understanding of topical drug administration will be advanced using nano gel developments to treat common ocular diseases such as glaucoma, cataracts, dry eye syndrome, bacterial keratitis, and linked medication-loaded contact lenses and natural active ingredients.

When noise becomes signal: a study of blink rate using an eye tracker

PurposeAlthough blink rate is considered important for digital eye strain and dry eye conditions, its assessment has been mostly manual. This study aimed at quantifying blink rate automatically using the Eyelink 1000 Plus eye tracker and comparing it with manual counting. Additionally, blink rate was correlated with reading eye movements and reading speed. MethodsThirty participants (mean age 26.8±3.5 years; 19 females) were enrolled. An on-screen reading task for 3 minutes duration, was repeated 3 times with a 2-minute break between the repetitions. During this task, eye movements and blinks were measured through the Eyelink 1000 Plus eye tracker. The blink was also counted manually by the examiner in real time from a video feed. ResultsThe blink rate obtained by the eye tracker (median [Q1, Q3]:11.7 [6.8,15.5] blinks/min) and manual counting (11.6 [7.1, 15.4] blinks/min) were comparable (p>0.5). No significant correlations were observed between the blink rate and any of the reading eye movement parameters except saccadic amplitude (Spearman's rho, rs =0.506). No statistically significant correlation was found between the blink rate and reading speed. ConclusionThe Eyelink 1000 Plus eye tracker gives a comparable blink rate compared to that obtained through manual counting. A positive correlation between the blink rate and saccade amplitude could indicate a coupled interaction between the two mechanisms to minimize visual loss during reading. The option of using this tracker to investigate blinks in dry eye and binocular vision disorders can be further explored.

Multidimensional immunotherapy for dry eye disease: current status and future directions

Multidimensional immunotherapy for dry eye disease: current status and future directions

In Situ Gelling Eye Drops of Tacrolimus with Improved Ocular Delivery and Therapeutic Efficacy.

In situ gelling eye drops of tacrolimus (FK506 Gel) were developed to address the formulation challenge of tacrolimus for anterior ocular inflammatory diseases. Both in silico and in vitro investigations were conducted to screen a suitable cyclodextrin species to increase the drug solubility. Guanosine was employed as the gelator and combined with inclusion complexes of tacrolimus in the presence of borate anions to obtain FK506 Gel, which gelated when came into contact with cations in tear fluid and led to the formation of a nanofibrous hydrogel. The versatility of our design to improve the solubility and ocular retention of the hydrophobic drug was demonstrated in vivo with coumarin 6 as a model drug. A mouse dry eye model was used to evaluate the therapeutic effects of FK506 Gel, which, in combination with the biocompatibility study, suggested that FK506 Gel served as a superior treatment for anterior ocular inflammatory diseases.

Clinically Probable Multiple System Atrophy Presenting Ptosis as an Early Manifestation

Many ocular features were found in patients with multiple system atrophy (MSA), which include dry eye, blepharospasm, eye movement problems, and blink reflex dysfunction. Some of these symptoms are associated with autonomic dysfunctions seen in MSA. We report a young clinically-probable MSA patient with bilateral ptosis at an early disease stage. Although there is no clear evidence that ptosis, in this case, was caused by abnormalities in the sympathetic cholinergic system, the selective impairment of sudomotor function implied an injured sympathetic cholinergic system secondary to MSA pathology. Ocular manifestations need more attention in clinical examinations of patients with MSA.

Pre and postoperative comparative evaluation of tear film stability and conjunctival impression cytology after phacoemulsification using clear corneal temporal incision

Abstract Introduction: Development of significant dry eye symptoms and visual disturbances after successful cataract surgery remains the common and unsatisfying experience for ophthalmologists. Corneal incision site and surgical technique contribute in ocular surface damage after cataract surgery. To assess the pre and post-operative conjunctival impression cytology and tear film stability after phacoemulsification by clear corneal temporal incision. Methodology: This prospective interventional study was conducted in department of ophthalmology at tertiary care teaching hospital. 72 patients were enrolled and the dry eye assessment was done considering the Schirmer’s test, tear meniscus height, tear breakup time and conjunctival impression cytology; preoperatively and then at 1 week and 4 weeks postoperatively. ANOVA and Post Hoc test were used for statistical analysis and p value of &lt;0.05 was considered significant. Results: Mean age of the patients was 59.86±9.56 years and most of the males were employed while females were mostly homemakers. The overall trend for dry eye tests showed significant (P&lt;0.0001 on ANOVA) increase at 1st week postoperatively, while the significant recovery was achieved by 4th week postoperatively. There was a significant decline (p&lt;0.0001) in goblet cell density (GCD) at 1st week, which was reversed by the 4th week postoperatively. Conclusion: The transient dry eye was seen in the patient’s undergoing phacoemulsification by 1st week postoperatively, which resolved spontaneously but partially with routine postoperative care by the 4th week follow up.

Early expression of osteopontin glycoprotein on the ocular surface and in tear fluid contributes to ocular surface diseases in type 2 diabetic mice.

Osteopontin (OPN) is a glycosylated, secreted phosphoprotein known to be elevated in both human and mouse retinas during various stages of diabetic retinopathy. However, its specific roles in modulating ocular surface dynamics and immune responses in diabetes remain unexplored. This study aims to investigate the role of OPN in the development of ocular surface disease (OSD) in type 2 diabetic (T2D) mice. Three- to four-week-old C57BL/6 wild-type (WT) and OPN-knockout (OPN-/-) mice were fed a high-fat diet (HFD) and were rendered diabetic by streptozotocin (STZ; 40 mg/kg body weight) in citrate buffer (vehicle); non-diabetic controls were injected with vehicle alone. Diabetes was confirmed if blood glucose levels were >200 mg/dL, measured 1-2 weeks post-STZ injection. Control, age- and sex-matched db/db diabetic mice fed a standard chow diet were also included in this study. Ocular surface inflammation was assessed using ELISA to quantify inflammatory cytokine proteins and wheat germ agglutinin (WGA) staining was utilized to highlight corneal surface irregularities. Clinical signs were evaluated by corneal fluorescein staining, tear production measurements, and tear sodium (Na+) concentration assessments. These evaluations were conducted 4, 6, 8 and 16-weeks post-diabetes onset in WT and OPN-/- mice and were compared to those obtained in non-diabetic controls. Statistical analysis was performed using a two-way ANOVA, with significance set at P < 0.05. Both WT and OPN-/- mice developed T2D within 4 and 8 weeks, respectively, following HFD + STZ treatment. Corneal OPN levels in WT diabetic mice increased ~2-fold at 2 weeks and ~4-fold at 16 weeks compared to non-diabetic controls, with similar elevations observed in their tear fluid. Diabetic db/db mice also exhibited elevated OPN levels in the blood and ocular surface, which persisted as diabetes progressed. Enhanced fluorescein staining, indicating corneal irregularities, appeared in WT mice at 8 weeks and in OPN-/- mice at 10 weeks post-T2D induction. Additionally, WGA staining showed a significant reduction in fluorescence intensity in WT mice treated with HFD and STZ, confirming corneal surface irregularities that were delayed in OPN-/- mice. Elevated tear sodium concentration was observed in both WT and OPN-/- diabetic mice without affecting tear production rates. Notably, OPN levels increased early, at week 2, following HFD and STZ treatment, preceding changes in interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and matrix metalloproteinase-9 (MMP-9). Upregulation of IL-6 became apparent at 6 weeks in WT mice and was delayed until 10 weeks in OPN-/- mice post-T2D induction. Elevated OPN levels were detected early post-T2D induction in diabetic WT and db/db mice corneas without initial subclinical changes. This early increase in OPN precedes other proinflammatory cytokines associated with eventual ocular surface inflammation as diabetes progresses. Persistence of OPN also correlated with clinical signs such as increased corneal surface irregularities and elevated tear Na+ concentration. Future research will explore OPN's role as a biomarker in ocular surface disease (OSD), including dry eye disease (DED), and investigate its impact on inflammatory processes and other mechanistic pathways in diabetic ocular complications.

Successful treatment of psoriasis vulgaris with ixekizumab in a patient with concurrent Sjögren’s syndrome presenting with dry eye and incomplete SLE

Successful treatment of psoriasis vulgaris with ixekizumab in a patient with concurrent Sjögren’s syndrome presenting with dry eye and incomplete SLE

Dry Eye in Diabetes: The Indian Diabetic and Endocrine Eye Diseases (INDEED) Review

Dry Eye in Diabetes: The Indian Diabetic and Endocrine Eye Diseases (INDEED) Review

Evaluation of traditional Chinese medicine tea bag TBDESJS in patients with Sjögren's syndrome and dry eye syndrome: A phase II pilot study.

Sjögren's syndrome (SJS) and dry eye syndrome (DES) are characterized by ocular dryness from inadequate tear production or excessive evaporation. To evaluate the effectiveness of TBDESJS (Chun-Yu-Ching-Hua-Yin, CYCHY), a TCM tea bag, in treating SJS and DES patients compared with healthy controls (NHC). This phase II pilot study included 100 participants (60 SJS, 30 DES, 10 NHC) across 8 weeks, assessing changes in Schirmer's test, OSDI, ESSPRI, PSQI, FIRST, and artificial tear usage, using repeated measurement ANOVA and Tukey's honestly significant difference (HSD) for analysis. Total 97 subjects completed the trial, for the left eye (OS) of Schirmer's test, significant improvements at 4, and 8 weeks were observed in SJS (0.13 ± 0.43-5.77 ± 2.87, and 7.60 ± 4.84 mm) and DES (0.21 ± 0.41-6.21 ± 2.97, and 7.86 ± 3.47 mm) (all p < .001). For the right eye (OD), significant improvements were observed in SJS (0.13 ± 0.39-6.77 ± 4.53, and 8.79 ± 5.92 mm) and DES (0.34 ± 0.55-6.59 ± 2.50, and 8.24 ± 3.42 mm) (all p < .001). Secondary outcomes showed reduced the dryness of ESSPRI scores in SJS (6.37 ± 1.97-5.57 ± 1.79, p < .001) and DES (6.10 ± 1.97-5.28 ± 2.23, p < .05). PSQI global scores improved significantly in all groups at 8 weeks (p < .05). Artificial tear usage decreased in SJS (4.93 ± 2.45-1.00 ± 0.82 times/day), DES (4.47 ± 1.99-0.66 ± 0.67 times/day) (all p < .001). No serious adverse events in this study. TBDESJS significantly improved tear production, ocular dryness, and sleep quality, indicating potential neural regulation, anti-inflammatory and immunomodulatory benefits. These findings advocate for TBDESJS (Chun-Yu-Ching-Hua-Yin, CYCHY)'s comprehensive therapeutic value in SJS and DES treatment, emphasizing the need for further research to understand long-term effects and mechanisms.