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Corticosteroid
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Phase 2
Waitlist Available
Research Sponsored by Bausch & Lomb Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 13
Awards & highlights
Approved for 30 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05% administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety visit 1 week post-treatment. This study will also investigate the relative efficacy of Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at the end of a 12-week treatment period.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 13
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4
Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4
Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values
+1 moreSecondary study objectives
Averaged Daily Soothe Lubricant Eye Drops Usage
Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13
Eye
+12 moreAwards & Highlights
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Lotemax Gel 0.5% and Restasis 0.05%Experimental Treatment3 Interventions
Participants will administer lotemax gel 0.5 % BID in both eyes (OU) for 2 weeks, then administer both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administer restasis emulsion 0.05% BID OU for 8 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Group II: Lotemax Gel 0.5%Experimental Treatment2 Interventions
Participants will administer lotemax gel 0.5% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Group III: Restasis 0.05%Active Control2 Interventions
Participants will administer restasis emulsion 0.05% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loteprednol etabonate
FDA approved
Cyclosporine
FDA approved
Povidone
FDA approved
Find a Location
Who is running the clinical trial?
Synteract, Inc.Industry Sponsor
20 Previous Clinical Trials
5,800 Total Patients Enrolled
Bausch & Lomb IncorporatedLead Sponsor
257 Previous Clinical Trials
58,144 Total Patients Enrolled
Susan HarrisStudy DirectorBausch Health Americas, Inc.