A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Ocular Hypertension Clinical Trial

Official title:

A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05335122
• Other study ID #: OTX-TIC-2020-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 16, 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Description:

This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are 18 years of age or older at the time of screening
• Provide written informed consent and are able to comply with all study requirements
• Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
• Have a negative pregnancy test result for women of childbearing potential at Baseline
• Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria:

• Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
• Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
• Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• OTX-TIC low dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
• OTX-TIC high dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
• Durysta, Bimatoprost Intracameral Implant 10 µg
Durysta is injected into the anterior chamber of the eye.

Locations

Country	Name	City	State
United States	Ocular Therapeutix, Inc.	Austin	Texas
United States	Ocular Therapeutix Inc	Carmel	Indiana
United States	Ocular Therapeutix, Inc.	Clearwater	Florida
United States	Ocular Therapeutix, Inc.	Cleveland	Ohio
United States	Ocular Therapeutix, Inc.	Cranberry Township	Pennsylvania
United States	Ocular Therapeutix, Inc.	Dallas	Texas
United States	Ocular Therapeutiux, Inc.	Delray Beach	Florida
United States	Ocular Therapeutix, Inc.	Dothan	Alabama
United States	Ocular Therapeutix, Inc.	Dover	New Jersey
United States	Ocular Therapeutix, Inc.	Durham	North Carolina
United States	Ocular Therapeutix, Inc.	El Paso	Texas
United States	Ocular Therapeutiux, Inc.	Fargo	North Dakota
United States	Ocular Therapeutix, Inc.	Fort Myers	Florida
United States	Ocular Therapeutix, Inc.	Houston	Texas
United States	Ocular Therapeutix, Inc.	Huntington Beach	California
United States	Ocular Therapeutix, Inc.	Irvine	California
United States	Ocular Therapeutix, Inc.	Kenosha	Wisconsin
United States	Ocular Therapeutix, Inc.	Los Angeles	California
United States	Ocular Therapeutix Inc	Oklahoma City	Oklahoma
United States	Ocular Therapeutix, Inc.	Pasadena	California
United States	Ocular Therapeutix, Inc.	Petaluma	California
United States	Ocular Therapeutix, Inc.	Philadelphia	Pennsylvania
United States	Ocular Therapeutix, Inc.	Redlands	California
United States	Ocular Therapeutix, Inc.	Rock Island	Illinois
United States	Ocular Therapeutix, Inc.	Roswell	Georgia
United States	Ocular Therapeutix, Inc.	Saint Joseph	Michigan
United States	Ocular Therapeutix, Inc.	Saint Joseph	Missouri
United States	Ocular Therapeutix Inc.	Saint Louis	Missouri
United States	Ocular Therapeutix, Inc.	Torrance	California
United States	Ocular Therapeutix, Inc.	Troy	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Outcome: IOP changes from Baseline	IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye	Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit]