Ocular Hypertension, Open-angle Glaucoma
Conditions
Keywords
Open-angle glaucoma, Ocular hypertension
Brief summary
The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
Interventions
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. * Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy. * Best corrected visual acuity of -0.6 logMAR or better in each eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Treatment with BAK preserved artificial tears within 30 days of Visit 1. * Known or suspected Sjogren's disease. * Uncontrolled IOP. * History or evidence of infectious or inflammatory ocular conditions. * Progressive retinal or optic nerve disease. * Ocular laser surgery within 3 months of Visit 1. * Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1. * Current use of punctal plugs or punctal cautery. * Use of systemic medications that has not been stable for 30 days prior to Visit 1. * Use of contact lens within 30 days of Visit 1. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) | Day 0, Day 84 | Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | Day 0, Day 84 | The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health. |
Participant flow
Recruitment details
Patients were recruited from 22 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for six months prior to Visit 1 were enrolled.
Pre-assignment details
236 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and completed the study (intent-to-treat): 215.
Participants by arm
| Arm | Count |
|---|---|
| Travoprost One drop self-administered in the study eye(s) once daily at night for 12 weeks | 109 |
| Latanoprost One drop self-administered in the study eye(s) once daily at night for 12 weeks | 106 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 8 |
Baseline characteristics
| Characteristic | Travoprost | Latanoprost | Total |
|---|---|---|---|
| Age Continuous | 66.3 years STANDARD_DEVIATION 12.1 | 69.0 years STANDARD_DEVIATION 10.4 | 67.6 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 66 Participants | 71 Participants | 137 Participants |
| Sex: Female, Male Male | 43 Participants | 35 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 117 | 3 / 119 |
| serious Total, serious adverse events | 1 / 117 | 2 / 119 |
Outcome results
Primary
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)
Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.
Time frame: Day 0, Day 84
Population: Intent-to-Treat: All patients who received test article and completed the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) | 0.7 Seconds | Standard Error 0.1 |
| Latanoprost | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) | 0.6 Seconds | Standard Error 0.2 |
Secondary
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
Time frame: Day 0, Day 84
Population: Intent-to-Treat: All patients who received test article and completed the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | -1.9 Units on a scale | Standard Error 1.2 |
| Latanoprost | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | 0.6 Units on a scale | Standard Error 1.5 |