Phase 2
N=68
OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Chronic Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT02062905 ↗Enrolled (actual)
68
Serious AEs
1.6%
Results posted
May 2016
Primary outcome: Primary: Ocular Itching — 1.80; 2.58; 1.72; 2.70 units on a scale (0 -4)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexamethasone (Drug); Placebo Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocular Therapeutix, Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
1.80; 2.58; 1.72; 2.70; 1.65; 2.53 | — |
| SECONDARY Conjunctival Redness |
1.60; 2.11; 1.53; 2.23; 1.54; 2.21 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- History of ocular surgical intervention within the past 3 months
- Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
- Use any of the following disallowed medications during the period indicated
Data sourced from ClinicalTrials.gov (NCT02062905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.