Travoprost Implant for Glaucoma

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ocular Therapeutix, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a small device that releases medication inside the eye to help patients with high eye pressure due to glaucoma or ocular hypertension. The medication helps fluid drain from the eye, reducing pressure and preventing vision problems.

Eligibility Criteria

This trial is for adults with Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT). Participants must be willing to stop their glaucoma medications as per study rules and not be at risk by doing so. Pregnant or breastfeeding individuals, those unresponsive to certain eye pressure-lowering drugs, or with uncontrolled diseases like severe diabetes are excluded.

Inclusion Criteria

I am 18 years old or older.

Women who could become pregnant must have a negative pregnancy test before starting the study.

Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk

+2 more

Exclusion Criteria

Eye drops for my condition did not work for me.

I do not have any uncontrolled illnesses like heart disease or diabetes.

I am not pregnant, breastfeeding, and if I can have children, I use birth control.

Participant Groups

The trial tests two doses of OTX-TIC Travoprost Intracameral Implant against a known treatment, Durysta Bimatoprost Implant. It aims to see how well these treatments lower eye pressure in patients with OAG or OHT over time and monitor safety.

3Treatment groups

Experimental Treatment

Active Control

Group I: OTX-TIC Low DoseExperimental Treatment1 Intervention

Travoprost Intracameral Implant low dose

Group II: OTX-TIC High DoseExperimental Treatment1 Intervention

Travoprost Intracameral Implant high dose

Group III: DurystaActive Control1 Intervention

Bimatoprost Intracameral Implant 10 µg