NCT01870856|TerminatedResults
Study Stopped
Primary efficacy was not demonstrated in Stage 1
Lid Wiper Epitheliopathy Trial
Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses
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Sponsor study identifier
interventional
187
0 countries
N/A
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
October 2013
Actual (reported)The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 4, 2013
Actual (reported)June 6, 2013
Actual (reported)July 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2013
Actual (reported)October 2013
Actual (reported)October 29, 2014
Actual (reported)Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.
Baseline, Week 2
Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
This outcome measure was not evaluated since primary efficacy was not demonstrated.
Baseline, Week 2
Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks
Baseline, Week 2
Spectacles per participant's habitual perscription worn for 2 weeks
Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
Delefilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
Per participant's habitual prescription
Silicone hydrogel single vision contact lenses
Anne Brobst, OD, FAAO
Alcon Research
187 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2013
First Posted
June 6, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
Hydrogel single vision contact lenses
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2013
Actual (reported)Study Completion
October 2013
Actual (reported)Last Updated
October 29, 2014
Results First Posted
October 29, 2014
Record last verified: 2014-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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