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

NCT ID: NCT02365519

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 514 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-09
• Study Completion Date: 2015-10-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LME636

LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye 3 times a day (TID) for 6 weeks

Group Type: EXPERIMENTAL

LME636 ophthalmic solution

Intervention Type: BIOLOGICAL

Vehicle

LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks

Group Type: PLACEBO_COMPARATOR

LME636 Vehicle

Intervention Type: BIOLOGICAL

Inactive ingredients used as a placebo comparator

Interventions

LME636 ophthalmic solution

Intervention Type: BIOLOGICAL

LME636 Vehicle

Inactive ingredients used as a placebo comparator

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Must sign written informed consent.
• Physician diagnosis of DED of at least 6 months prior to Visit 1.
• Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis.
• Respond as "often" or "constantly" to the question "How often do your eyes feel uncomfortable?".
• Best Corrected Visual Acuity (BCVA) of 55 or greater in each eye as measured by ETDRS at Visit 1.

Exclusion Criteria

• Presence of any acute infection or non-infectious ocular condition in either eye within 1 month of Visit 1.
• Contact lens wearers, defined as individuals who cannot be without their contact lenses for the entire duration of the study.
• Any chronic ocular degenerative condition that in the opinion of the Investigator could possibly advance during the time course of the study.
• Use of biologics treatments, such as systemic biologic anti-cytokines, including anti-TNFα drugs, or immunosuppressive therapy for the treatment of severe systemic autoimmune disorders.
• Diseases or conditions affecting the ocular surface that are associated with clinically significant scarring and or destruction of conjunctiva and/or cornea.
• Unwilling to abstain from topical ocular non-prescription medications during the course of the study, including concomitant use of artificial tears, gels, lubricants, re-wetting drops, allergy drops, etc. after Visit 2.
• Use of nasal, inhaled, systemic (including injections), or topical corticosteroids within 30 days of Visit 1.
• Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Institutes for BioMedical Research

OTHER

Sponsor Role: collaborator

Alcon, a Novartis Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Clinical Manager, GCRA

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Other Identifiers

LME636-2202

Identifier Type: -

Identifier Source: org_study_id