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Corticosteroid

Lotemax Gel 0.5% and Restasis 0.05% for Dry Eye Syndrome

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

Study 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 weeks
Treatment ~ Varies
Follow Up ~baseline, week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

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
Povidone
FDA approved
Cyclosporine
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
251 Previous Clinical Trials
57,317 Total Patients Enrolled
Susan HarrisStudy DirectorBausch Health Americas, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
2013. "Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01817582.
~8 spots leftby May 2025
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