Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Open-Angle Glaucoma, Ocular Hypertension
Brief summary
The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.
Detailed description
This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).
Interventions
DRUGTravoprost ophthalmic solution, 0.003%
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
* Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension. * Qualifying intraocular pressure at both eligibility visits. * Understand and sign an informed consent form. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control. * Severe central visual field loss in either eye. * Chronic, recurrent or severe inflammatory eye disease. * Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen). * Any abnormality preventing reliable applanation tonometry. * Hypersensitivity to prostaglandin analogs or to any component of the study medications. * Therapy with another investigational agent within 30 days prior to the Screening Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM) | As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). |
Participant flow
Recruitment details
Subjects were recruited from 60 investigational centers, including 52 in the US, 2 each in Sweden, Germany, and Austria, and 1 each in Spain and Finland.
Pre-assignment details
Of the 1099 enrolled, 235 did not meet inclusion/exclusion criteria and were exited from the study prior to randomization. This reporting group includes all randomized subjects (864).
Participants by arm
| Arm | Count |
|---|---|
| Travoprost 0.003% Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months | 442 |
| TRAVATAN Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months | 421 |
| Total | 863 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 |
| Overall Study | Inadequate Control of IOP | 1 | 5 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Noncompliance | 1 | 0 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Patient Decision Unrel to Adverse Event | 3 | 3 |
Baseline characteristics
| Characteristic | Travoprost 0.003% | TRAVATAN | Total |
|---|---|---|---|
| Age, Customized 18 to 64 years | 189 Participants | 193 Participants | 382 Participants |
| Age, Customized ≥ 65 years | 253 Participants | 228 Participants | 481 Participants |
| Sex: Female, Male Female | 269 Participants | 246 Participants | 515 Participants |
| Sex: Female, Male Male | 173 Participants | 175 Participants | 348 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 442 | 64 / 421 |
| serious Total, serious adverse events | 5 / 442 | 7 / 421 |
Outcome results
Primary
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)
As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time frame: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)
Population: The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 2 at 10 AM | 18.6 millimeters mercury (mmHg) | Standard Error 0.16 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 6 at 4 PM | 18.0 millimeters mercury (mmHg) | Standard Error 0.16 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 6 at 8 AM | 19.3 millimeters mercury (mmHg) | Standard Error 0.16 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Month 3 at 8 AM | 19.2 millimeters mercury (mmHg) | Standard Error 0.17 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 2 at 4 PM | 18.0 millimeters mercury (mmHg) | Standard Error 0.16 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Month 3 at 10 AM | 18.3 millimeters mercury (mmHg) | Standard Error 0.17 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 6 at 10 AM | 18.5 millimeters mercury (mmHg) | Standard Error 0.16 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Month 3 at 4 PM | 18.0 millimeters mercury (mmHg) | Standard Error 0.16 |
| Travoprost 0.003% | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 2 at 8 AM | 19.4 millimeters mercury (mmHg) | Standard Error 0.16 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Month 3 at 4 PM | 18.0 millimeters mercury (mmHg) | Standard Error 0.17 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 2 at 8 AM | 19.5 millimeters mercury (mmHg) | Standard Error 0.17 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 2 at 10 AM | 18.6 millimeters mercury (mmHg) | Standard Error 0.16 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 2 at 4 PM | 18.3 millimeters mercury (mmHg) | Standard Error 0.16 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 6 at 8 AM | 19.3 millimeters mercury (mmHg) | Standard Error 0.17 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 6 at 10 AM | 18.6 millimeters mercury (mmHg) | Standard Error 0.17 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Week 6 at 4 PM | 18.1 millimeters mercury (mmHg) | Standard Error 0.17 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Month 3 at 8 AM | 19.3 millimeters mercury (mmHg) | Standard Error 0.18 |
| TRAVATAN | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | Month 3 at 10 AM | 18.6 millimeters mercury (mmHg) | Standard Error 0.18 |