Glaucoma, Ocular Hypertension
Conditions
Keywords
Ocular surface health, OSDI, TFBUT, Glaucoma, Ocular hypertension, Corneal staining
Brief summary
The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.
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
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye). * Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1. * IOP controllable and stable on the study medication alone (both eyes). * Believed to have ocular surface disease (OSD). * Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye. * Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs. * Current use of punctual plugs. * Women of childbearing potential not using reliable means of birth control. * Women who are pregnant or lactating. * Suspected or diagnosed with Sjogrens's syndrome. * Current use of any brand of artificial tears containing BAK. * Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study. * Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1. * Current use of contact lenses within 30 days of Visit 1. * Participation in any other investigational study within 30 days prior to 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 (TBUT) | 12 weeks (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 | 12 weeks (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 21 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and abnormal TBUT were enrolled.
Pre-assignment details
231 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received the test article and completed the study (intent-to-treat): 226.
Participants by arm
| Arm | Count |
|---|---|
| Travoprost One drop self administered in the study eye(s) once daily at night for 12 weeks | 112 |
| Latanoprost One drop self-administered in the study eye(s) once daily at night for 12 weeks | 114 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Travoprost | Latanoprost | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 78 Participants | 70 Participants | 148 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 44 Participants | 78 Participants |
| Sex: Female, Male Female | 74 Participants | 66 Participants | 140 Participants |
| Sex: Female, Male Male | 38 Participants | 48 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 116 | 0 / 115 |
| serious Total, serious adverse events | 1 / 116 | 1 / 115 |
Outcome results
Primary
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
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: 12 weeks (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 (TBUT) | 0.8 seconds | Standard Deviation 1.5 |
| Latanoprost | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT) | 1.1 seconds | Standard Deviation 2.7 |
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: 12 weeks (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 | -0.0 Units on a scale | Standard Deviation 11.4 |
| Latanoprost | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | -1.3 Units on a scale | Standard Deviation 16.7 |