Impact Of Dry Eye On Everyday Life Research Articles

Environmental and Occupational Triggers of Dry Eye Symptoms in the Ahsa Region of Saudi Arabia: A Cross-Sectional Study.

This cross-sectional study aimed to investigate the associations between environmental and occupational factors and the prevalence of dry eye symptoms among participants from the Ahsa region of Saudi Arabia. Participants from urban, rural, and suburban areas seeking medical care at primary health centers were recruited through systematic random sampling. Data on demographics, exposures, and ocular health were captured using a structured questionnaire. Dry eye symptoms were evaluated using the Ocular Surface Disease Index (OSDI), Impact of Dry Eye on Everyday Life (IDEEL), and Symptom Assessment in Dry Eye (SANDE) questionnaires. Logistic regression analysis examined the relationships between environmental/occupational factors and the prevalence of dry eye symptoms. Key exposures included particulate matter (PM) (60%), low humidity (55%), wind/dust (50%), prolonged computer use (65%), and chemical irritants (45%). These factors were significantly associated with an increased prevalence of dry eye symptoms, with the following odds ratios (ORs): PM (1.85, 95% CI: 1.35-2.52), low humidity (1.45, 95% CI: 1.05-2.00), wind and dust (1.60, 95% CI: 1.20-2.14), prolonged computer use (2.10, 95% CI: 1.55-2.85), and chemical irritants (1.75, 95% CI: 1.30-2.35). All associations were statistically significant (p < 0.05). The use of protective equipment was associated with reduced odds of dry eye symptoms (OR 0.60, 95% CI: 0.42-0.85, p = 0.03). This study identifies significant associations between specific environmental and occupational exposures and the prevalence of dry eye symptoms. Reducing modifiable exposures through policy, workplace enhancements, and clinical preventative strategies is essential to mitigate the burden of dry eye symptoms related to modern lifestyles and technology.

Prevalence of dry eye disease among visual display terminal office users in Uyo, Nigeria

Context: Dry eye disease (DED) results from loss of tear film homeostasis. Increase use of visual display terminals (VDT) by individuals and professionals increases the risk of DED.&#x0D; Objective: This study is aimed to determine the prevalence of dry eye disease among office workers who use visual display terminals in Uyo.&#x0D; Methods: A descriptive, cross-sectional study of VDT office workers aged 19-65 years. Multi-stage sampling technique was used to recruit participants. Self-administered Impact of Dry Eye on Everyday Life (IDEEL) questionnaire and ocular examination was done to gather data; such data was analyzed using SPSS version 22.0&#x0D; Results: Prevalence of dry eye disease (DED) was 5.8% (95% CI 3.44 - 8.16). Mean Schirmer’s 1 was 21.60 ± 9.29mm, mean TBUT was 9.74 ± 2.48s, mean IDEEL score was 76.15 ± 25.47. There was a statistically significant association between DED and educational level 7.56(p-value 0.02), hours of visual display terminal use per day 10.72(p-value 0.013), and use of air conditioning 7.66(p-value 0.006). Multivariate regression analysis to identify predictors of dry eye was statistically significant for module 1(Symptom bother) of the dry eye questionnaire (p-value 0.01, odds ratio 12.71,), tear break up time in the left eye (p-value 0.00, odds ratio 38.67), and Schirmer 1 test in the right eye (p-value 0.00, odds ratio 30.83)`.&#x0D; Conclusion: The prevalence of DED increases with the number of hours spent on VDT Periodic medical and psychological evaluation of VDT users to identify office workers most at risk should be carried out by employers of labour.

Quality of Life in Digital Device Users Who are Treated with Systane Hydration PF.

To understand the impact of Systane Hydration PF on dryness symptoms and quality of life in digital device users and to determine if participants prefer either the unit-dose or multi-dose dispensing system of Systane Hydration PF. This 2-week, three visit study recruited regular digital device users. Participants were required to score ≤80 on the Impact of Dry Eyeon Everyday Life (IDEEL) Quality of Life (QoL) Work domain and between 13 and 32 on the Ocular Surface Disease Index (OSDI) questionnaire. Participants were randomized to either Systane Hydration PF unit-dose or multi-dose for 1 week and switched to the alternative dosing system for the second week. Participations were evaluated by completing the full IDEEL-QoL module and OSDI questionnaire at each visit. Likert surveys were completed to probe dispensing system preferences. Thirty participants with a mean ± SD age of 28.6 ± 12.0 years (70% female) were recruited. Participants had significant improvements in all three IDEEL-QoL domains as well as in OSDI scores (all p < 0.0001). Participants had similar preferences for the two dispensing systems, though they were more likely to indicate that they thought that the multi-dose bottle was more environmentally friendly than the unit-dose vials. Digital device users with dry eye symptoms had meaningful improvements in eye comfort and quality of life scores after being treated with Systane Hydration PF for 2 weeks. Participants did not have a clear dispensing system preference suggesting that the best dispensing system may depend on the patient.

Repository Corticotropin Injection (Acthar® Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study.

IntroductionNoninfectious keratitis is a painful corneal inflammation treated with topical cyclosporine and other immunosuppressants. Additional treatment options are needed for keratitis that does not improve with standard therapies. Repository corticotropin injection (RCI; Acthar® Gel) is approved to treat severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, including keratitis. This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneously twice weekly for 12 weeks followed by a 4-week taper. Assessments included all domains of the Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire, Ocular Discomfort and 4-Symptom Questionnaire, and Visual Analog Scale (VAS). Corneal fluorescein and conjunctival lissamine green staining, Conjunctival Redness Scale, tear production (Schirmer’s test), visual acuity, slit lamp examination, and intraocular pressure were also assessed. Safety was evaluated via treatment-emergent adverse events. Analyses were performed using the modified intent-to-treat (mITT) population (patients who received ≥ 1 dose of RCI and contributed any post-baseline efficacy data).ResultsIn the mITT population (N = 35), 50.0% (95% confidence interval, 33.2% to 66.8%) of patients experienced clinically important improvements in the symptom bother domain of the IDEEL Questionnaire at week 12 of RCI therapy. All domains of the IDEEL and the Ocular Discomfort and 4-Symptom Questionnaire showed improvements at week 12 of RCI treatment. The most pronounced improvements in the VAS at week 12 were for eye dryness and eye discomfort. Corneal staining, conjunctival staining, conjunctival redness, and tear production showed early improvements that were sustained through week 12. No new safety signals for RCI were identified.ConclusionsRCI is safe and effective for refractory severe noninfectious keratitis that has not improved with other approved therapies.Trial registration numberClinicalTrials.gov NCT04169061.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-021-00400-y.

A systematic review assessing the quality of patient reported outcomes measures in dry eye diseases.

Patient-reported outcome measures (PROMs) can provide valuable insights on the impact of a disease or treatment on a patient's health-related quality of life. In ophthalmology, particularly in dry eye disease (DED) and ocular surface disease (OSD), it is unclear whether the available PROMs were developed using comprehensive guidelines. To address this, we evaluated the methodological quality of studies assessing the psychometric properties of PROMs in DED and OSD [PROSPERO registration number CRD42019142328]. Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the quality of the studies evaluating the psychometric properties of PROMs used in DED and OSD. The search strategy (S3 Table) retrieved 5,761 records, 573 duplicates were removed, 5,188 abstracts were screened and 127 full-text articles were retrieved for further review. Of these, 118 full-text articles did not meet the eligibility criteria and were excluded. Reference list and citation searching, identified an additional 8 articles bringing the total numbers of papers reviewed to 17. In general, psychometric properties such as content validity, measurement error and structural validity were not assessed by the studies included in this review. Studies reviewing The Impact of Dry Eye on Everyday Life (IDEEL) presented with the highest quality scores together with the Ocular Surface Disease Index (OSDI) questionnaire. The quality of studies evaluating PROMs in DED and OSD was considered using the COSMIN standards. The majority of the studies evaluating PROMs included in this review did not meet the recommended COSMIN criteria and the quality of the PROMs evaluated is not assured. Further evaluation of their psychometric properties is required if these are going to be used in clinical practice or research.

PSS3 Topline Patient-Reported Outcome Results from a Multicenter, Open-Label, Phase 4 Study of Repository Corticotropin Injection in Patients with Refractory Severe Noninfectious Keratitis

Repository corticotropin injection (RCI; Mallinckrodt Pharmaceuticals) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides approved for the treatment of keratitis. This analysis of topline patient-reported outcome results from a multicenter, open-label, phase 4 study of RCI in patients with refractory severe noninfectious keratitis was conducted to assess quality of life (QoL) and symptomatic improvements (NCT04169061). Patients were ≥18 years old with severe keratitis despite previous treatment with topical cyclosporine, lifitegrast, or an immunosuppressant. Patients received 80 U RCI subcutaneously twice weekly for 12 weeks. Analyses evaluated the change from baseline through week 12 on the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire, Visual Analogue Scale (VAS), and Ocular Discomfort Score (ODS). One-sample t tests (null hypothesis: no change) were used for statistical analyses, with significance vs baseline determined as p<0.05. Analyses were performed using the modified intent-to-treat (mITT) population (patients who received ≥1 dose of RCI and contributed any postbaseline efficacy data). Topline results in the mITT population (N=35) showed significant improvements from baseline at every time point assessed after initiation of RCI treatment in 4 of 6 dimensions of the IDEEL questionnaire (ie, emotional impact, impact on daily activities, symptom bother, and treatment-related bother scores); significant improvements from baseline at weeks 6 and 12 were observed for the IDEEL impact on work score. VAS scores for eye discomfort, eye dryness, foreign body sensation, pain, and photophobia significantly improved at all measured time points after initiation of RCI. ODS showed significant improvements from baseline at every time point assessed after RCI initiation for the overall score and for the symptoms of dryness, grittiness, and stinging. Topline results of this open-label study showed that RCI significantly improved QoL and symptom measures in patients with refractory severe noninfectious keratitis.

A Comparison of Efficacy and Safety of Two Lipid-Based Lubricant Eye Drops for the Management of Evaporative Dry Eye Disease.

PurposeThe aim of this study was to compare the efficacy of two lipid-based lubricant eye drops in patients with lipid-deficient dry eye.MethodsThis Phase IV, multicenter, prospective, double-masked study enrolled adults (aged ≥18 years) who had a tear film breakup time (TFBUT) of ≤15 seconds(s), and unanesthetized Schirmer I test of ≥3 mm to ≤12 mm in at least one eye, at both screening and baseline visits. Eligible patients (n=231) were randomized (1:1) and received either Systane® Balance (SYSB; n=117) or Refresh® Optive Advanced (RFO-Ad, n=114), four-times a day, for 35 days. The primary endpoint was non-inferiority for change from baseline in TFBUT at Day 35 (non-inferiority was established if the lower limit of the 95% confidence interval (CI) for the difference between the treatment groups was > –1.0 s); secondary endpoints (test of superiority) were change in TFBUT and global ocular discomfort visual analog scale (VAS) score at Day 35. Other endpoints included the impact of dry eye on everyday life (IDEEL) treatment satisfaction scores (inconvenience and effectiveness) and safety.ResultsAt Day 35, the mean change from baseline in TFBUT was 0.998 s in the SYSB and 0.868 s in the RFO-Ad groups with a treatment difference: 0.130 s; (95% CI −0.34, 0.60; P<0.0001) demonstrating non-inferiority of SYSB to RFO-Ad. The global ocular discomfort VAS scores improved in both groups, with a mean change from baseline of –9.7 and –8.8 in SYSB and RFO-Ad groups (treatment difference –0.8; P=0.62), respectively. No meaningful difference was observed in IDEEL treatment effectiveness and treatment inconvenience scores between SYSB vs RFO-Ad (P>0.05 for treatment difference). Both treatments were well tolerated.ConclusionSYSB lubricant eye drops were non-inferior to RFO-Ad for improvement in TFBUT in patients with lipid-deficient dry eye. Both lubricant eye drops improved TFBUT and ocular discomfort scores in patients with lipid-deficient dry eye.

Patient-Reported Burden of Dry Eye Disease in the United States: Results of an Online Cross-Sectional Survey

To evaluate functional vision, general health status, and work productivity in individuals with and without dry eye disease (DED). Cross-sectional study. Setting: General US population (2018). Adults ≥18 years with (n= 1003) or without (n= 1006) self-reported DED. All respondents completed the National Eye Institute Visual Function Questionnaire (VFQ) and the EuroQol 5-dimensions 5-levels (EQ-5D-5L). All respondents with DED completed the eye dryness score (EDS) visual analogue scale, Ocular Comfort Index (OCI), and Work Productivity and Activity Impairment (WPAI) questionnaire. Half of respondents with DED completed the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire; the other half completed the Dry Eye Questionnaire 5 (DEQ-5) and Standardized Patient Evaluation of Eye Dryness (SPEED), McMonnies, and Symptom Assessment in Dry Eye (SANDE) questionnaires. All analyses were descriptive. Respondents with DED reported more comorbidities, greater exposure to adverse environmental conditions, and lower (worse) mean (standard deviation) scores on the modified Rasch-scored 28-item VFQ (VFQ-28R) total score (68.8 [11.9] vs 81.2 [12.7]) and EQ-5D-5L (0.82 [0.13] vs 0.88 [0.14]) than respondents without DED. Respondents with DED and EDS ≥60 (highest discomfort) fared worse on OCI, VFQ-28R, and WPAI than respondents with DED and EDS <40 (lowest discomfort). Similar findings were observed with IDEEL, DEQ-5, SPEED, McMonnies, and SANDE scores. There is a substantial burden of DED on functional vision, general health status, and productivity; and further, these parameters appear to worsen with increasing EDS.

Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study.

BackgroundAn artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.MethodsIn a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) <2 units.ResultsIn total, 99 patients were randomized (HPG-HA, n= 50; SH, n= 49). At day 42, the least square (LS) mean ± SE change from baseline in TOSS was −1.16±0.24 and −0.92±0.23 in the HPG-HA and SH groups, respectively, and the treatment difference was −0.24±0.33 (95% CI −0.90 to 0.42). Noninfe-riority was demonstrated as the upper limit of the 95% CI was <2 units. LS mean change from baseline at day 42 for HPG-HA vs SH was −3.18 (P=0.4817) in IDEEL treatment-effectiveness scores, −12.56 (P=0.0001) in treatment-inconvenience scores, and 0.30 seconds (P=0.5789) in TFBUT.ConclusionThe HPG-HA dual-polymer formulation was noninferior to the SH lubricant eye-drops for improvement in ocular surface staining in DED. HPG-HA did not show improvement over SH in IDEEL treatment-satisfaction scores. No new safety findings were reported.

Development and validation of the Chinese version of dry eye related quality of life scale

BackgroundTo develop the Chinese version of quality of life scale for dry eye patients based on the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire and to assess the reliability and validity of the developed scale.MethodsThe original IDEEL was adapted cross-culturally to Chinese language and further developed following standard procedures. A total of 100 Chinese patients diagnosed with dry eye syndrome were included to investigate the psychometric properties of the Chinese version of scale. Psychometric tests included internal consistency (Cronbach’s ɑ coefficients), construct validity (exploratory factor analysis), and known-groups validity (the analysis of variance).ResultsThe Chinese version of Dry Eye Related Quality of Life (CDERQOL) Scale contains 45 items classified into 5 domains. Good to excellent internal consistency reliability was demonstrated for all 5 domains (Cronbach’s ɑ coefficients range from 0.716 to 0.913). Construct validity assessment indicated a consistent factorial structure of the CDERQOL scale with hypothesized construct, with the exception of “Dry Eye Symptom-Bother” domain. All domain scores were detected with significant difference across three severity groups of dry eye patients (P < 0.05) except for “Satisfaction with Treatment” domain, indicating good known-groups validity.ConclusionsThe results indicated that the CDERQOL scale is a reliable and valid instrument for patients with dry eye syndrome among Chinese population, and could be used as a supplementary diagnostic and treatment-effectiveness measure.

Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye

AimsTo demonstrate non-inferiority of a hydroxypropyl guar/polyethylene glycol/propylene glycol lubricating eye-drop (HPG/PEG/PG) compared with an osmoprotective carboxymethylcellulose/glycerine eye-drop (O/CMC) for ocular surface staining.MethodsThis was a multicentre, randomised, observer-masked, parallel-group study....

Dry eye specific quality of life in veterans using glaucoma drops.

To evaluate the frequency of ocular surface symptoms and their potential impact on dry eye specific quality of life (QoL) in patients using versus not using glaucoma medications. The study was a single-center, cross-sectional survey of patients seen at the Miami Veterans Affairs (VA) ophthalmology and optometry clinics from June to August, 2010. Patients were invited to complete the Dry Eye Questionnaire 5 (DEQ5) and the Impact of Dry Eye on Everyday Life (IDEEL) at their visit. Of 1348 patients seen in the Miami VA eye clinics during this three-month period, 467 patients completed the DEQ5 and 391 responded to both questionnaires. Outcome measures comprised ocular surface symptoms and their impact on dry eye specific QoL in patients using versus not using glaucoma drops. An increasing number of glaucoma drops was significantly associated with an increased percentage of severe dry eye symptoms: no medications, 25% (n=89/353); 1 or 2 medications, 27% (n=17/62); 3 or more medications, 40% (n=21/52); p=0.03 (Armitage's test for linear-trend in proportions). There was an association between increasing number of drops and decreasing emotional well-being scores (linear p<0.001; quadratic p=0.029). Black patients had higher dry eye symptoms and lower emotional QoL scores compared to white patients at every level of medication use. An increasing number of glaucoma medications were associated with an increased frequency of severe dry eye symptoms and decreased emotional QoL. Additionally, dry eye specific emotional QoL was more severely affected in black versus white patients.

Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose

BackgroundThe purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks of treatment with Systane® Gel Drops or Refresh Liquigel® lubricant eye drops.MethodsPatients aged ≥18 years with a sodium fluorescein corneal staining sum score of ≥3 in either eye and best-corrected visual acuity of 0.6 logarithm of the minimum angle of resolution or better in each eye who were using a lubricant eye gel or ointment for dry eye were included in this randomized, parallel-group, multicenter, double-blind trial. Patients were randomized to four times daily Systane® Gel Drops (polyethylene glycol 400 0.4% and propylene glycol 0.3%) or Refresh LiquiGel® Drops (carboxymethylcellulose sodium 1%) for 6 weeks. The primary efficacy outcome was mean change from baseline to week 6 in sodium fluorescein corneal staining. Supportive efficacy outcomes included conjunctival staining, tear film break-up time, Patient Global Assessment of Improvement, Impact of Dry Eye on Everyday Life (IDEEL) Treatment Satisfaction/Treatment Bother Questionnaire, Single Symptom Comfort Scale, and Ocular Symptoms Questionnaire. The safety analysis comprised recording of adverse events.ResultsIn total, 147 patients (Systane group, n=73; Refresh group, n=74; mean ± standard deviation age, 57±16 years) were enrolled and included in the safety and efficacy analyses. Corneal staining was significantly reduced from baseline to week 6 for Systane and Refresh (−3.4±2.5 and −2.5±2.6 units, respectively; P<0.0001, t-test), with a significantly greater improvement with Systane versus Refresh (P=0.0294). Results for conjunctival staining, tear film break-up time, and patient-reported outcome questionnaires were not statistically different between groups. No safety issues were identified; adverse events were reported by 19% of patients with Systane and 30% of patients with Refresh eye drops.ConclusionSystane Gel Drops were associated with significantly better corneal staining scores versus Refresh Liquigel eye drops in patients with dry eye. Supportive efficacy outcomes were not significantly different between groups. Both treatments were well tolerated.

Impact of Ocular Surface Symptoms on Quality of Life in a United States Veterans Affairs Population

To evaluate the impact of ocular surface symptoms on quality of life in a veteran population receiving eye care services. Cross-sectional survey study. setting: Miami Veterans Affairs Medical Center (VAMC). patient population: Patients seen at the eye clinic between June and August 2010 were asked to fill out the Dry Eye Questionnaire 5 (DEQ5) and the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire. main outcome measures: Correlation between ocular surface symptoms and functionality. Four hundred eighty-nine patients elected to fill out the DEQ5 questionnaire (36% response rate). The mean age of respondents was 66 years (standard deviation 12). Ninety-four percent were male; 62% were white and 37% were black. Using the DEQ5 as a surrogate measure of ocular surface symptoms, 65% of respondents reported at least mild ocular surface symptoms (DEQ5 ≥6) and 27% of them reported severe symptoms (DEQ5 ≥12). Black subjects had a 2-fold increased risk of severe symptoms compared to white subjects (odds ratio 2.06, 95% confidence interval 1.33-3.19). Several medications were associated with a significantly increased risk of severe symptoms, including glaucoma medications (1.7-fold increase), antidepressants (2.3-fold increase), and antihistamines (2.1-fold increase). There was an inverse correlation between DEQ5 and IDEEL scores with regard to ability to perform activities of daily living (n = 391, r = -0.54, P < .001), emotional well-being (n = 386, r = -0.63, P < .001), and the ability to work (n = 205, r = -0.57, P < .001). Fifty percent of patients with severe symptoms had documentation that their symptoms were addressed during the visit. Severe ocular surface symptoms reduce the quality of life of Miami VAMC veterans. Eye care professionals should be vigilant in eliciting ocular surface complaints from their patients.

PSS32 Impact of Dry Eye on Everyday Life (Ideel) - Symptom Bother: Estimating Cut-off Scores for Dry Eye Severity Groups

The aims of the study were to estimate score ranges associated with dry eye severity based on the Impact of Dry Eye on Everyday Life (IDEEL) Symptom Bother (SB) domain, and to evaluate the overall performance of the SB domain.

Development and validation of the impact of dry eye on everyday life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients

ObjectiveTo develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL).MethodsDevelopment and validation of the IDEEL occurred in four phases: 1) focus groups with 45 dry eye patients to develop a draft instrument, 2) item generation, 3) pilot study to assess content validity in 16 patients and 4) psychometric validation in 210 subjects: 130 with non-Sjögren's keratoconjunctivitis sicca, 32 with Sjögren's syndrome and 48 controls, and subsequent item reduction.ResultsFocus groups identified symptoms and the associated bother, the impact of dry eye on daily life and the patients' satisfaction with their treatment as the central concepts in patients' experience of dry eye. Qualitative analysis indicated that saturation was achieved for these concepts and yielded an initial 112-item draft instrument. Patients understood the questionnaire and found the items to be relevant indicating content validity. Patient input, item descriptive statistics and factor analysis identified 55 items that could be deleted. The final 57-item IDEEL assesses dry eye impact constituting 3 modules: dry eye symptom-bother, dry eye impact on daily life comprising impact on daily activities, emotional impact, impact on work, and dry eye treatment satisfaction comprising satisfaction with treatment effectiveness and treatment-related bother/inconvenience. The psychometric analysis results indicated that the IDEEL met the criteria for item discriminant validity, internal consistency reliability, test-retest reliability and floor/ceiling effects. As expected, the correlations between IDEEL and the Dry Eye Questionnaire (a habitual symptom questionnaire) were higher than between IDEEL and Short-Form-36 and EuroQoL-5D, indicating concurrent validity.ConclusionThe IDEEL is a reliable, valid and comprehensive questionnaire relevant to issues that are specific to dry eye patients, and meets current FDA patient-reported outcomes guidelines. The use of this questionnaire will provide assessment of the impact of dry eye on patient dry eye-related quality of life, impact of treatment on patient outcomes in clinical trials, and may aid in treatment effectiveness evaluation.

Comparing the Discriminative Validity of Two Generic and One Disease-Specific Health-Related Quality of Life Measures in a Sample of Patients with Dry Eye

The purpose of this study was to compare the discriminative properties of two generic health-related quality of life (QoL) instruments (SF-36 and EQ-5D) and a newly developed disease-specific patient-reported outcomes instrument (Impact of Dry Eye on Everyday Life (IDEEL)) to distinguish between different levels of dry eye severity. Assessment of 210 people: 130 with non-Sjogren's Keratoconjunctivitis Sicca (non-SS KCS), 32 with Sjögren's Syndrome (SS) and 48 controls; comparison of SF-36, EQ-5D, and IDEEL age-adjusted data by dry eye severity levels. Severity was assessed based on diagnosis (non-SS KCS, SS, control), patient-report (none, very mild, mild, moderate, severe, extremely severe) and clinician-report (none, mild, moderate, severe). Discriminative validity results were consistent for all instruments. Significant differences between severity levels were found with most SF-36 scales (P < 0.05), all EQ-5D scales (P < 0.05), and all IDEEL scales (P < 0.0001), except for Treatment Satisfaction. IDEEL scales consistently outperformed the generic QoL measures regardless of the severity criterion used. Most SF-36 scales outperformed the EQ-5D QoL scale, but the EQ-5D visual analog scale outperformed the SF-36 scales, except for General Health Perceptions. The disease-specific IDEEL scales are better able to discriminate between severity levels than the majority of the generic QoL scales. Preliminary evidence demonstrates that the IDEEL will be sensitive to QoL changes over time, although further testing in controlled longitudinal studies is needed.