Phase 3
Completed N=96
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
Source: ClinicalTrials.gov NCT04050865 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) — 1.80; 2.69 units on a scale
◆ Published Evidence
Emerging
3citations · ~2 / year
A Randomized, Multicenter Phase 3 Clinical Trial Evaluating Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis.
Summary
The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.
Linked Publications
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A Randomized, Multicenter Phase 3 Clinical Trial Evaluating Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) |
1.80; 2.69 | — |
| PRIMARY Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) |
1.72; 2.71 | — |
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
- History of IOP increase as a result of steroid treatment
- A female who is currently pregnant, planning a pregnancy, or lactating
Data sourced from ClinicalTrials.gov (NCT04050865) and the linked publication. 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.