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

NCT02365519 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2018-07-02

Study results available
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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.

Conditions

  • Dry Eye

Interventions

BIOLOGICAL

LME636 ophthalmic solution

BIOLOGICAL

LME636 Vehicle

Inactive ingredients used as a placebo comparator

Sponsors & Collaborators

  • Novartis Institutes for BioMedical Research

    collaborator OTHER

  • Alcon, a Novartis Company

    lead INDUSTRY

Principal Investigators

  • Senior Clinical Manager, GCRA · Alcon, A Novartis Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-09
Primary Completion
2015-10-16
Completion
2015-10-16
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365519 on ClinicalTrials.gov