A Phase 2 interventional study of BTV100 Low dose and BTV100 Mid dose in Dry Eye, sponsored by BioTheraVision, Inc.. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by BioTheraVision, Inc. · Phase 2, Interventional, and Treatment
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).
At the screening visit/Visit 1 (Day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (BID), morning and evening (at least 6-hour interval). At the time of the screening visit/Visit 1, subjects will be instructed to discontinue all over the counter (OTC) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study.
At Baseline/Visit 2 (Day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle.
Approximately120 subjects will be randomized. Subjects will be randomized to one of the following 4 treatment groups. Following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (IP) into each eye twice daily, morning and evening (at least 6-hour interval). Subjects will be instructed to return to the clinic to be evaluated at Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), and Day 85 (Visit 6).
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 123 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with BioTheraVision, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1% Cevimeline Ophthalmic Solution
Drug: BTV100 Low dose
2% Cevimeline Ophthalmic Solution
Drug: BTV100 Mid dose
4% Cevimeline Ophthalmic Solution
Drug: BTV100 High dose
Vehicle
Drug: Placebo
1% Cevimeline Ophthalmic Solution
2% Cevimeline Ophthalmic Solution
4% Cevimeline Ophthalmic Solution
Placebo
Schirmer test
Change from baseline in unanesthetized Schirmer test of study eye
Time frame: Day 85
Schirmer test
Proportion of subjects with an increase in unanesthetized Schirmer of 10 mm or more for study eye
Time frame: Day 15, 29, 57 and 85.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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