Evaluation of BTV100 in Subjects With Dry Eye Disease
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Dry Eye
In brief
This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).
Key facts
- Study ID
- NCT06543303
- Run by
- BioTheraVision, Inc.
- People needed
- 120
- Starts
- 2024-12-31
- Expected to finish
- 2026-02-15
- Last updated by the study team
- 2025-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older (regardless of gender).
- Provide written informed consent.
- Willing and able to follow instructions and be available for required study visits during the study.
- Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
- Ongoing moderate to severe Dry Eye Disease (DED) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at Visit 1 and Visit 2:
You may not qualify if…
- Known hypersensitivity or contraindication to the study drug or its components.
- Within 28 days prior to the screening visit (Visit 1), have taken or used: Topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine)
- Current use of contact lenses or anticipated use during the study.
Where it is running
- Cataract and Eye Surgery Centre, Victoria — Doncaster East, Victoria, Australia (enrolling)
- Sydney Eye Hospital — Sydney, Australia (enrolling)
- Chang Gung Memorial Hospital-Kaohsiung Branch — Kaohsiung City, Taiwan (enrolling)
- Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (enrolling)
- Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
- Chang Gung Memorial Hospital-LinKou Branch — Taoyuan, Taiwan (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.