A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert

Last updated: June 7, 2023
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Completed

Phase

3

Condition

Ocular Hypertension

Glaucoma

Treatment

Ophthalmic Insert

Clinical Study ID

NCT04061044
CLN-Protocol-0047
  • Ages > 18
  • All Genders

Study Summary

To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Had prior bilateral treatment and completion, through a minimum of week 12, of theOTX-16-002 trial
  • Are informed of the nature of the study and subject is able to comply with studyrequirements and visit schedule for one year
  • Have provided written informed consent, approved by the appropriate InstitutionalReview Board

Exclusion

Exclusion Criteria:

  • Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
  • Had punctal or canaliculi related adverse events during the OTX-16-002 trial whichrequired discontinuation (e.g., canaliculitis)
  • Used prohibited medications during the OTX-16-002 study, or the period betweenOTX-16-002 and this trial (with the exception of short term medication used to treatan adverse event or rescue therapy)
  • Missed more than 2 visits during participation in the OTX-16-002 trial

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Ophthalmic Insert
Phase: 3
Study Start date:
July 10, 2018
Estimated Completion Date:
September 22, 2020

Connect with a study center

  • ApexEye

    Cincinnati, Ohio 45242
    United States

    Site Not Available

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