Phase 3
Completed N=86
OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Chronic Allergic Conjunctivitis
Source: ClinicalTrials.gov NCT02988882 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 — 2.04; 2.31 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 Post-CAC (Conjunctival Allergen Challenge) at Visit 6 |
2.02; 2.37 | — |
| PRIMARY Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 |
2.07; 2.41 | — |
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 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
- Use any of the disallowed medications during the period indicated
- History of IOP increase as a result of steroid treatment
Data sourced from ClinicalTrials.gov (NCT02988882). 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.