OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Last updated: March 2, 2018
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Completed

Phase

3

Condition

Eye Disorders/infections

Allergy

Treatment

N/A

Clinical Study ID

NCT02445326
OTX-14-007
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Has a positive history of ocular allergies and a positive skin test reaction to aperennial allergen and a seasonal allergen

  • Has a positive bilateral CAC reaction to a perennial allergen within minutes ofinstillation

Exclusion

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 herpeticinfection at any visit

  • Use any of the disallowed medications during the period indicated

  • History of IOP increase as a result of steroid treatment

Study Design

Total Participants: 73
Study Start date:
April 01, 2015
Estimated Completion Date:
September 30, 2015