Ocular Hypertension, Open-angle Glaucoma
Conditions
Keywords
Open-angle glaucoma, ocular hypertension
Brief summary
The purpose of the 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 90 days. Referred to as travoprost.
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 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. * Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol. * Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. * Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1. * Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears. * Best corrected visual acuity of -0.6 logMAR or better in each eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article. * Use of contact lenses within 30 days of Visit 1. * Use of contact lenses during the study. * Participation in an investigational drug or device study within 30 days of entering this study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | Day 0, Day 90 | 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. A negative number represents a perceived improvement in ocular health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Corneal Fluorescein Staining Score = 0 | Day 90 | The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (\>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed. |
Participant flow
Recruitment details
Patients were recruited from 78 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for at least one month immediately prior to Visit 1 were enrolled.
Pre-assignment details
705 patients were enrolled in this study. 701 patients were evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy visit (intent to treat): 652.
Participants by arm
| Arm | Count |
|---|---|
| Travoprost One drop self-administered in the study eye(s) once daily for 90 days | 318 |
| Latanoprost One drop self-administered in the study eye(s) once daily for 90 days | 334 |
| Total | 652 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 7 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Missing | 1 | 0 |
| Overall Study | Noncompliance | 4 | 3 |
| Overall Study | Nonspecified | 2 | 2 |
| Overall Study | Protocol Violation | 21 | 14 |
| Overall Study | Withdrawal by Subject | 8 | 7 |
Baseline characteristics
| Characteristic | Travoprost | Latanoprost | Total |
|---|---|---|---|
| Age Continuous | 66.3 years STANDARD_DEVIATION 11.8 | 66.3 years STANDARD_DEVIATION 10.9 | 66.3 years STANDARD_DEVIATION 11.4 |
| Gender Female | 185 participants | 216 participants | 401 participants |
| Gender Male | 132 participants | 118 participants | 250 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 353 | 0 / 348 |
| serious Total, serious adverse events | 4 / 353 | 6 / 348 |
Outcome results
Primary
Mean Change at Day 90 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. A negative number represents a perceived improvement in ocular health.
Time frame: Day 0, Day 90
Population: Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost | Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | -9.1 Units on a scale | Standard Error 1 |
| Latanoprost | Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | -10.2 Units on a scale | Standard Error 0.9 |
Secondary
Percentage of Patients With Corneal Fluorescein Staining Score = 0
The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (\>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.
Time frame: Day 90
Population: Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Travoprost | Percentage of Patients With Corneal Fluorescein Staining Score = 0 | 37.6 Percentage of patients |
| Latanoprost | Percentage of Patients With Corneal Fluorescein Staining Score = 0 | 38.7 Percentage of patients |