Phase 3 Completed N=73 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT02445326 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcomePrimary: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 — 1.68; 2.66 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 This can indicate results are unpublished — a known publication-bias signal.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	1.70; 2.74	—
PRIMARY Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6	1.44; 1.76	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.