NCT06152861

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

Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Travoprost Ophthalmic Topical Cream low-dose	travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
DRUG	Travoprost Ophthalmic Topical Cream mid-dose	travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
DRUG	Travoprost Ophthalmic Topical Cream high-dose	travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes
DRUG	Timolol maleate ophthalmic solution, 0.5%	timolol maleate ophthalmic solution, 0.5% twice daily (morning \& evening) to both eyes
DRUG	Travoprost Ophthalmic Solution, 0.004%	travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-12-01
• Last updated: 2023-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study