Phase 2
Completed 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
Source: ClinicalTrials.gov NCT02062905 ↗
Enrolled (actual)
68
Serious AEs
1.6%
Results posted
May 2016
Primary outcomePrimary: Ocular Itching — 1.80; 2.58; 1.72; 2.70 units on a scale (0 -4)
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
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 | — |
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. Informational only — not medical advice.