Phase 3
N=73
OTX-14-007: A Phase 3 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: NCT02445326 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 — 1.68; 2.66 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Placebo Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocular Therapeutix, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 |
1.70; 2.74 | — |
| PRIMARY Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 |
1.70; 2.74 | — |
| PRIMARY Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 |
1.70; 2.74 | — |
| PRIMARY Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 |
1.44; 1.76 | — |
| PRIMARY Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 |
1.44; 1.76 | — |
| PRIMARY Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 |
1.44; 1.76 | — |
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 refractive surgery (including LASIK procedures)
- 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 (NCT02445326). 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.