Phase 2/3 Study Evaluating Efficacy and Safety of OTX-DP for Treatment of Chronic Allergic Conjunctivitis
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Ocular |
| Therapuetic Areas: | Ophthalmology, Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | March 2014 |
| End Date: | September 2014 |
| Contact: | Emily Schoemmell |
| Email: | eschoemmell@oraclinical.com |
| Phone: | 978-685-8900 |
A Single Center, Randomized, Double-Masked, Vehicle Controlled Phase 2/3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)
The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained
release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the
treatment of the signs and symptoms of chronic allergic conjunctivitis.
release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the
treatment of the signs and symptoms of chronic allergic conjunctivitis.
Inclusion Criteria:
- be at least 18 years of age of either sex and any race
- have a positive history of ocular allergies and a positive skin test reaction to a
perennial allergen
- have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as
measured using an ETDRS chart
Exclusion Criteria:
- have known contraindications or sensitivities to the use of any of the
investigational product medication or components
- have had ocular surgical intervention within three (3) months prior to Visit 1 or
during the study and/or a history of refractive surgery within the past 3 months
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