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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 is a Phase 2 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 102 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01817582
The ClinicalTrials.gov registry entry for NCT01817582 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Restasis is the first listed.
NCT01817582 reports 0 study locations.
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.
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