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

NCT02365519 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LME636-2202
• Study Type: interventional
• Target: 514
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye

Keywords

LME636; dry eye disease; efficacy; ocular discomfort

Outcome Measures

Primary Outcomes (5)

• Mean Change From Baseline in Global Ocular Discomfort Score at Day 71

  Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.

  Baseline (Day 43), Day 71

• Best Corrected Visual Acuity (BCVA)

  Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.

  Baseline (Day 43), Day 57, Day 71, Day 85

• Intraocular Pressure (IOP)

  IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.

  Baseline (Day 43), Day 57, Day 71, Day 85

• Percentage of Subjects With Increase in Slit-Lamp Parameter From Baseline to Any Visit

  Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.

  Baseline (Day 43), Day 57, Day 71, Day 85

• Percentage of Subjects With Increase in Dilated Fundus Parameter From Baseline to Any Visit

  The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.

  Baseline (Day 43), Day 57, Day 71, Day 85

Secondary Outcomes (3)

• Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71

  Baseline (Day 43), Day 71

• Percentage of Subjects With LME636 Serum Concentrations Below the Lower Limit of Quantification (LLOQ)

  Day 15, Day 29, Day 43, Day 57, Day 71, Day 85

• Percentage of Subjects With Anti-LME636 Antibodies by Visit

  Day 15, Day 29, Day 43, Day 57, Day 71, Day 85

Study Arms (2)

LME636

EXPERIMENTAL

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

Biological: LME636 ophthalmic solution

Vehicle

PLACEBO COMPARATOR

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

Biological: LME636 Vehicle

Interventions

LME636 ophthalmic solution BIOLOGICAL

LME636

LME636 Vehicle BIOLOGICAL

Inactive ingredients used as a placebo comparator

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon, a Novartis Company: lead
• Novartis Institutes for BioMedical Research: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Ophthalmology & Medical Lead, Translational Medicine, NIBR
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Senior Clinical Manager, GCRA

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 19, 2015
• Study Start: March 9, 2015
• Primary Completion: October 16, 2015
• Study Completion: October 16, 2015
• Last Updated: July 2, 2018
• Results First Posted: November 24, 2017

Record last verified: 2017-10