Phase 3 N=86 Randomized Double-blind Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT02988882 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 — 2.04; 2.31 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: Apr 2016

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	—
PRIMARY Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6	2.02; 2.37	—

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) 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

View full record on ClinicalTrials.gov →

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.