At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 96 enrolled
Drug / intervention
Dexamethasone, 0.4mg +1 moredrug
Likely dose
Dexamethasone, 0.4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CLN-0052, A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluation the Efficacy and Safety of OTX-DP for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)
In Brief
A Phase 3 clinical trial evaluating Dexamethasone, 0.4mg and Placebo plug with no drug for Allergic Conjunctivitis. Completed, enrolled 96 participants across 6 sites.
Detailed Summary
The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedAug 2019
Primary CompletionFeb 2020
TodayJul 2026
First PostedAug 8, 2019
Enrollment StartAug 5, 2019
Primary CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.9 years ago
Interventions
Dexamethasone, 0.4mgdrug
Ophthalmic Insert
Placebo plug with no drugdevice
Ophthalmic Insert