Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension

NCT06152861 | Unknown Phase 2 FDA Drug

• 1 other identifier: GLK-311-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change from baseline in mean diurnal IOP in the study eye

  Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye

  Day 29

Study Arms (5)

Travoprost Ophthalmic Topical Cream low-dose

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Topical Cream low-dose

Travoprost Ophthalmic Topical Cream mid-dose

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Topical Cream mid-dose

Travoprost Ophthalmic Topical Cream high-dose

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Topical Cream high-dose

Timolol maleate ophthalmic solution, 0.5%

ACTIVE COMPARATOR

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

Drug: Timolol maleate ophthalmic solution, 0.5%

Travoprost ophthalmic solution, 0.004%

ACTIVE COMPARATOR

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

Drug: Travoprost Ophthalmic Solution, 0.004%

Interventions

Travoprost Ophthalmic Topical Cream low-dose DRUG

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

Travoprost Ophthalmic Topical Cream low-dose

Travoprost Ophthalmic Topical Cream mid-dose DRUG

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

Travoprost Ophthalmic Topical Cream mid-dose

Travoprost Ophthalmic Topical Cream high-dose DRUG

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

Travoprost Ophthalmic Topical Cream high-dose

Timolol maleate ophthalmic solution, 0.5% DRUG

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

Timolol maleate ophthalmic solution, 0.5%

Travoprost Ophthalmic Solution, 0.004% DRUG

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

Travoprost ophthalmic solution, 0.004%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Glaukos Clinical Study Site

Newport Beach, California, 92663, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Study Director

  Glaukos Corporation

  STUDY DIRECTOR

Central Study Contacts

Study Clinical Trial Associate

CONTACT

949-367-9600; SVea@glaukos.com

Study Manager

CONTACT

949-367-9600; PBraswell@glaukos.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: November 15, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)