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The effects of lubricant eye drops on visual function as measured by the Inter-blink interval Visual Acuity Decay test.

ABSTRACT: OBJECTIVE:The purpose of the current study was to evaluate the effects of two marketed ocular lubricants on the visual decay in dry eye patients using the Inter-blink interval Visual Acuity Decay (IVAD) test. METHODS:This controlled, randomized, double-masked crossover study compared the effects of a polyethylene glycol/propylene glycol-based (PEG/PG) tear and a carboxymethylcellulose sodium (CMC)/glycerin tear on the visual acuity decay between blinks of dry eye patients. At visit 1 (Day 0), baseline IVAD measurements were recorded prior to instillation of a single drop of randomized study medication. IVAD testing was repeated at 15-, 45-, and 90-minutes post-instillation. Reading rate and functional blink rate were also evaluated. At the second visit (Day 7 +/- 3), study procedures were repeated using crossover treatment. RESULTS:Forty-eight (48) subjects with dry eye (61.1 +/- 14.8 years old, 79.2% female, 95.8% white) completed the study. Treatment with the PEG/PG-based tear demonstrated statistically significantly longer time to one-line loss of best-corrected visual acuity (BCVA) as determined by the IVAD test at 90 minutes post-instillation compared to the CMC/glycerin tear (P = 0.0365). Measurements of median time at BCVA, reading rate, and functional blink rate were similar for both treatments. Both formulations were well tolerated in the population studied. CONCLUSIONS:Treatment with the PEG/PG-based tear demonstrated statistically significant improved maintenance of visual acuity between blinks at 90 minutes post-instillation compared to the CMC/glycerin tear. This is the first study to demonstrate the ability of an artificial tear to extend visual acuity maintenance between blinks, as measured by the IVAD test.

SUBMITTER: Torkildsen G

PROVIDER: S-EPMC2754081 | biostudies-literature | 2009

REPOSITORIES: biostudies-literature

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The effects of lubricant eye drops on visual function as measured by the Inter-blink interval Visual Acuity Decay test.

Torkildsen Gail G

Clinical ophthalmology (Auckland, N.Z.) 20090924

<h4>Objective</h4>The purpose of the current study was to evaluate the effects of two marketed ocular lubricants on the visual decay in dry eye patients using the Inter-blink interval Visual Acuity Decay (IVAD) test.<h4>Methods</h4>This controlled, randomized, double-masked crossover study compared the effects of a polyethylene glycol/propylene glycol-based (PEG/PG) tear and a carboxymethylcellulose sodium (CMC)/glycerin tear on the visual acuity decay between blinks of dry eye patients. At visi ...[more]

PMID: 19789659

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Project description:IntroductionThe study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED).MethodsThis was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18 years, with tear breakup time (TBUT) ≤ 10 s for both eyes, dry eye questionnaire-5 (DEQ-5) "watery eyes" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 at days 0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2 days. Primary endpoints were change from baseline at day 28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day 28 ± 2; symptom relief (5-point Likert scale) at day 28 ± 2, and safety.ResultsOf 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0 years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day 28 for symptoms of aching/sore eyes (change from baseline - 1.0 ± 1.1), burning/stinging eyes (change from baseline - 1.1 ± 0.9), and tired eyes (change from baseline - 1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day 28 (change from baseline - 0.9 ± 1.0, p < 0.0001). Corneal staining at day 28 was comparable to baseline. TBUT improved from baseline to day 28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular).ConclusionsPG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28 days, with no new safety concerns.Trial registrationClinicalTrials.gov Identifier, NCT05056155.

Dataset Information

The effects of lubricant eye drops on visual function as measured by the Inter-blink interval Visual Acuity Decay test.

Publications

The effects of lubricant eye drops on visual function as measured by the Inter-blink interval Visual Acuity Decay test.

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