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NCT01817582 · ClinicalTrials.gov registry record · Phase 2
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
A Phase 2 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT01817582: Completed Phase 2 study, sponsored by Bausch & Lomb Incorporated.
NCT01817582 is a Phase 2 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01817582, a Phase 2 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
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.
Primary Outcome
Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the National Eye Institute (NEI) grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regio
Interventions
- DRUG Restasis
- DRUG Lotemax
- DRUG Soothe® Lubricant Eye Drops
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2013-05-17 |
| Est. Completion | 2014-01-10 |
| Phase | Phase 2 |
What the finished NCT01817582 record still lists
NCT01817582 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Restasis is the first listed.
NCT01817582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01817582 about?
NCT01817582 is a clinical study titled "Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)". 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% tr...
What is the current status of trial NCT01817582?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2013-05-17. Estimated completion is 2014-01-10.
What interventions are being tested in trial NCT01817582?
The interventions under investigation include: Restasis (DRUG), Lotemax (DRUG), Soothe® Lubricant Eye Drops (DRUG).
Who is sponsoring clinical trial NCT01817582?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01817582's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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