Recruiting
Phase 2

Travoprost

Sponsor:

Glaukos Corporation

Code:

NCT06152861

Conditions

Open Angle Glaucoma

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Travoprost Ophthalmic Topical Cream low-dose

Travoprost Ophthalmic Topical Cream mid-dose

Travoprost Ophthalmic Topical Cream high-dose

Timolol maleate ophthalmic solution, 0.5%

Travoprost Ophthalmic Solution, 0.004%

Study Details

Brief summary:

The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.

Conditions

Open Angle Glaucoma

Ocular Hypertension

Study ID

NCT06152861

Start date

Nov 15, 2023

Status verified date

Nov, 2023

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female, 18 years of age or older at the Screening Visit;
  • Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
  • Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
  • Qualifying IOP in the study eye;
  • Best-corrected visual acuity of approximately 20/80 Snellen in each eye

Exclusion Criteria:

  • Sensitivity or allergy to travoprost or timolol;
  • Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
  • History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
  • History of cerebrovascular insufficiency;
  • Any form of glaucoma other than open-angle glaucoma
  • Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
  • Non-qualifying prior surgeries or procedures in either eye

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Travoprost Ophthalmic Topical Cream low-dose

Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days

experimental: Travoprost Ophthalmic Topical Cream mid-dose

Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days

experimental: Travoprost Ophthalmic Topical Cream high-dose

Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days

active comparator: Timolol maleate ophthalmic solution, 0.5%

Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days

active comparator: Travoprost ophthalmic solution, 0.004%

Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days

Interventions

Travoprost Ophthalmic Topical Cream low-dose

travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes

Travoprost Ophthalmic Topical Cream mid-dose

travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes

Travoprost Ophthalmic Topical Cream high-dose

travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes

Timolol maleate ophthalmic solution, 0.5%

timolol maleate ophthalmic solution, 0.5% twice daily (morning \& evening) to both eyes

Travoprost Ophthalmic Solution, 0.004%

travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes

Primary outcome measure

  • change from baseline in mean diurnal IOP in the study eye [ Time Frame: Day 29 ]

Central Contacts and Locations

Central contacts

Study Clinical Trial Associate

949-367-9600SVea@glaukos.com

Study Manager

949-367-9600PBraswell@glaukos.com

Locations

Glaukos Clinical Study Site

Recruiting

Newport Beach, California, United States, 92663

Contacts

Glaukos Study Manager

949-367-9600PBraswell@glaukos.com

More Information

Sponsor

Glaukos Corporation

Last update posted

Dec 6, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2023-12-06.