At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 514 enrolled
Drug / intervention
LME636 ophthalmic solution +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-masked, Vehicle-controlled Study of LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease
In Brief
A Phase 2 clinical trial evaluating LME636 ophthalmic solution and LME636 Vehicle for Dry Eye. Completed, enrolled 514 participants.
Detailed Summary
The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when administered topically for up to 42 days, in subjects with severe dry eye disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
Countries--
CollaboratorsNovartis Institutes for BioMedical Research
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartMar 2015
Primary CompletionOct 2015
TodayJul 2026
First PostedFeb 19, 2015
Enrollment StartMar 9, 2015
Primary CompletionOct 16, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.4 years ago
Interventions
LME636 ophthalmic solutionbiological
LME636 Vehiclebiological
Inactive ingredients used as a placebo comparator