Clinical trial NCT02365519: LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease
Official title: A Randomized, Double-masked, Vehicle-controlled Study of LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: LME636
dry eye disease
efficacy
ocular discomfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Novartis Institutes for BioMedical Research
First posted: 2015-02-19
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* Other protocol-specified inclusion criteria may apply.

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.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Global Ocular Discomfort Score at Day 71
timeFrame: Baseline (Day 43), Day 71
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline (Day 43), Day 57, Day 71, Day 85
measure: Intraocular Pressure (IOP)
timeFrame: Baseline (Day 43), Day 57, Day 71, Day 85
measure: Percentage of Subjects With Increase in Slit-Lamp Parameter From Baseline to Any Visit
timeFrame: Baseline (Day 43), Day 57, Day 71, Day 85
measure: Percentage of Subjects With Increase in Dilated Fundus Parameter From Baseline to Any Visit
timeFrame: Baseline (Day 43), Day 57, Day 71, Day 85
Secondary outcomes:
measure: Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71
timeFrame: Baseline (Day 43), Day 71
measure: Percentage of Subjects With LME636 Serum Concentrations Below the Lower Limit of Quantification (LLOQ)
timeFrame: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85
measure: Percentage of Subjects With Anti-LME636 Antibodies by Visit
timeFrame: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Senior Clinical Manager, GCRA
role: STUDY_DIRECTOR
References: