Glaucoma
Conditions
Keywords
Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma
Brief summary
The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOP).
Interventions
DRUGTravoprost/Timolol Maleate BAK-Free Fixed Combination
Commercially marketed Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes. * On a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit. * IOP between 19 and 35 mmHg at any time of day in at least 1 eye. * Best corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye. * Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator. * Corneal dystrophies in either eye. * Risk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment. * Any disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study. * Women who are pregnant or lactating. * Participation in any other investigational study within 30 days prior to the Screening Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline) | 12 weeks | Goldmann applanation tonometry will be performed at the baseline visit and the 12-week visit to record IOP. Change in IOP will be calculated. IOP will be measured in mmHg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who reach target IOP (≤18mmHg) | 12 weeks | Goldmann applanation tonometry will be performed at the 12-week visit to record IOP. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18mmHg to the overall study population. |
| Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline | 12 weeks | An OSDI questionnaire will be completed by the subject at the baseline visit and at the 12-week visit. For each visit, an overall OSDI score will be calculated using individual item responses, and the change in OSDI score from baseline will be calculated. |
| Change in ocular hyperemia score at final visit from baseline | 12 weeks | Ocular hyperemia will be assessed by qualified personnel at the baseline visit and again at the 12-week visit, and change from baseline will be calculated. |
Countries
Brazil
Outcome results
None listed