Open Angle Glaucoma, Ocular Hypertension
Conditions
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%.
Interventions
DRUGTravoprost Ophthalmic Topical Cream low-dose
travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
DRUGTravoprost Ophthalmic Topical Cream mid-dose
travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
DRUGTravoprost 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% twice daily (morning & evening) to both eyes
travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in mean diurnal IOP in the study eye | Day 29 | Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye |
Countries
United States
Contacts
Primary ContactStudy Clinical Trial Associate
Backup ContactStudy Manager
Outcome results
None listed