OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Last updated: September 10, 2019
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Completed

Phase

3

Condition

Vision Loss

Inflammation

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT02089113
OTX-14-003
  • Ages > 18
  • All Genders

Study Summary

The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a cataract and is expected to undergo clear corneal cataract surgery withphacoemulsification and implantation of a posterior chamber lens

  • Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 orbetter in both eyes

Exclusion

Exclusion Criteria:

  • Any intraocular inflammation in the study eye present during the screening slit lampexamination

  • Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening

  • Any intraocular inflammation in the study eye present during the screening slit lampexamination

Study Design

Total Participants: 241
Study Start date:
April 01, 2014
Estimated Completion Date:
March 31, 2015

Connect with a study center

  • Fichte, Endl, and Elmer Eyecare

    Amherst, New York 14228
    United States

    Site Not Available

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