Ocular Hypertension, Open-angle Glaucoma
Conditions
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 latanprost.
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 medication other than the study medication for the duration of the study, including artificial tears. * Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (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 | Baseline, Day 90 | The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point 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 90-day OSDI score and reported as change. 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 the total number of patients analyzed. |
Participant flow
Recruitment details
Patients were recruited from 70 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
726 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy study visit (intent-to-treat): 678.
Participants by arm
| Arm | Count |
|---|---|
| Travoprost One drop self-administered in the study eye(s) once daily for 90 days | 343 |
| Latanoprost One drop self-administered in the study eye(s) once daily for 90 days | 335 |
| Total | 678 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 10 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Noncompliance | 1 | 2 |
| Overall Study | Other not specified | 1 | 3 |
| Overall Study | Protocol Violation | 6 | 7 |
| Overall Study | Withdrawal by Subject | 0 | 9 |
Baseline characteristics
| Characteristic | Travoprost | Latanoprost | Total |
|---|---|---|---|
| Age Continuous | 67.1 years STANDARD_DEVIATION 11 | 67.8 years STANDARD_DEVIATION 10.8 | 67.5 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 211 Participants | 230 Participants | 441 Participants |
| Sex: Female, Male Male | 132 Participants | 105 Participants | 237 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 363 | 0 / 363 |
| serious Total, serious adverse events | 5 / 363 | 7 / 363 |
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 point 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 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
Time frame: Baseline, 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. An Observed Case analysis (OC) was performed for the ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost | Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | -11.3 Units on a scale | Standard Error 0.9 |
| Latanoprost | Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | -11.4 Units on a scale | Standard Error 1 |
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 the 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. An Observed Case analysis (OC) was performed for the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Travoprost | Percentage of Patients With Corneal Fluorescein Staining Score = 0 | 37.1 percentage of patients |
| Latanoprost | Percentage of Patients With Corneal Fluorescein Staining Score = 0 | 40.0 percentage of patients |