NCT02365519

LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease

A Randomized, Double-masked, Vehicle-controlled Study of LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Alcon, a Novartis Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is organized into 2 phases. Following a 2-week identification phase, eligible subjects with severe dry eye disease (DED) will be randomized into the treatment phase and will be dispensed study treatment for 10 weeks.

Conditions

• Dry Eye

Interventions

Type	Name	Description
BIOLOGICAL	LME636 ophthalmic solution
BIOLOGICAL	LME636 Vehicle	Inactive ingredients used as a placebo comparator

Timeline

• Start date: 2015-03-09
• Primary completion: 2015-10-16
• Completion: 2015-10-16
• First posted: 2015-02-19
• Last updated: 2018-07-02
• Results posted: 2017-11-24

Regulatory

• FDA-regulated drug study