Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma, Hypertension
Brief summary
The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open-angle glaucoma or confirmed ocular hypertension. * Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2. * Sign an informed consent form. * Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures. * Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension. * History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye. * History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. * Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye. * Severe central visual field loss in either eye. * Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule. * History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker. * History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure (IOP) combined across all visits and timepoints | Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM) | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit | Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM) | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). |
Outcome results
None listed