Status:
COMPLETED
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 symptom...
Eligibility Criteria
Inclusion
- Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
- Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation
Exclusion
- History of refractive surgery (including LASIK procedures) within the past 2 years
- History of retinal detachment, diabetic retinopathy, or active retinal disease
- Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
- History of IOP increase as a result of steroid treatment
- A female who is currently pregnant, planning a pregnancy, or lactating
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04050865
Start Date
August 5 2019
End Date
February 28 2020
Last Update
October 7 2021
Active Locations (6)
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1
Vision Institute
Colorado Springs, Colorado, United States, 80907
2
The Eye Care Institute
Louisville, Kentucky, United States, 40206
3
Andover Eye Associates
Raynham, Massachusetts, United States, 02767
4
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133