At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 enrolled
Drug / intervention
Dexamethasone +1 moredrug
Likely dose
Dexamethasone ophthalmic suspension (OTX-DP)AI-extracted
Key inclusion· 2
- ✓Positive history of ocular allergies with positive skin test reaction to both a perennial allergen and a seasonal allergen
- ✓Positive bilateral CAC reaction to a perennial allergen within minutes of instillation
Key exclusion· 5
- ✕Refractive surgery (including LASIK) within the past 2 years
- ✕History of retinal detachment, diabetic retinopathy, or active retinal disease
- ✕Active ocular infection or positive history of ocular herpetic infection at any visit
- ✕Prior history of intraocular pressure increase as a result of steroid treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)
In Brief
A Phase 3 clinical trial evaluating Dexamethasone and Placebo Vehicle for Chronic Allergic Conjunctivitis. Completed, enrolled 86 participants.
Detailed Summary
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Allergic Conjunctivitis
Countries--
CollaboratorsORA, Inc.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
Primary CompletionApr 2016
First PostedDec 2016
TodayJul 2026
First PostedDec 9, 2016
Enrollment StartJun 1, 2015
Primary CompletionApr 27, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.6 years ago
Interventions
Dexamethasonedrug
Placebo Vehicleother