Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
Conditions
Keywords
Glaucoma, Ocular Hypertension, Open-Angle Glaucoma, Intraocular Pressure
Brief summary
The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in at least one eye. * Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic therapy or on the study medicine alone. * Willing to discontinue the use of all other ocular hypotensive medications prior to receiving study medication and for the entire course of the study. * Able to follow instructions, self instill study article, and attend all study visits. * Best-corrected Snellen visual acuity of 20/200 or better in each eye. * Sign Ethics Committee reviewed and approved informed consent form. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations used in this study. * Any abnormality preventing applanation tonometry in either eye. * Dry eye previously or currently being treated with punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids. * Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * Intraocular conventional or laser surgery \>3 months prior to consent. * Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. * Progressive retinal or optic nerve disease from any cause. * Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to Screening or an anticipated change in dosage during the course of the study. * Any clinically significant, serious, or severe medical condition. * Women of childbearing potential who are pregnant, lactating, or not using reliable means of birth control. * Participation in any other study within 30 days prior to Screening. * Use of any systemic (oral), injectable or topical steroids. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mean Intraocular Pressure (IOP) | Week 6 | IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean IOP at Each After Office Hour Evaluation Timepoint | Week 6: 4 pm, 6 pm, 8 pm | IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. |
Participant flow
Recruitment details
Subjects were recruited from 2 study centers located in the US.
Pre-assignment details
This reporting group includes all enrolled subjects. A washout-period based on prior medication preceded Period 1 dispense.
Participants by arm
| Arm | Count |
|---|---|
| Overall Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 6 Weeks | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 58.7 years STANDARD_DEVIATION 11.41 |
| Region of Enrollment United States | 84 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 84 | 0 / 84 |
| serious Total, serious adverse events | 0 / 84 | 0 / 84 |
Outcome results
Primary
Overall Mean Intraocular Pressure (IOP)
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.
Time frame: Week 6
Population: Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TRAVATAN | Overall Mean Intraocular Pressure (IOP) | 17.45 millimeters mercury (mmHg) | Standard Deviation 2.664 |
| LUMIGAN | Overall Mean Intraocular Pressure (IOP) | 17.22 millimeters mercury (mmHg) | Standard Deviation 2.605 |
Secondary
Mean IOP at Each After Office Hour Evaluation Timepoint
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.
Time frame: Week 6: 4 pm, 6 pm, 8 pm
Population: Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRAVATAN | Mean IOP at Each After Office Hour Evaluation Timepoint | 4 pm (20 hours post dose) | 17.74 millimeters mercury (mmHg) | Standard Deviation 3.099 |
| TRAVATAN | Mean IOP at Each After Office Hour Evaluation Timepoint | 6 pm (22 hours post dose) | 17.52 millimeters mercury (mmHg) | Standard Deviation 2.836 |
| TRAVATAN | Mean IOP at Each After Office Hour Evaluation Timepoint | 8 pm (24 hours post dose) | 17.06 millimeters mercury (mmHg) | Standard Deviation 2.84 |
| LUMIGAN | Mean IOP at Each After Office Hour Evaluation Timepoint | 8 pm (24 hours post dose) | 17.26 millimeters mercury (mmHg) | Standard Deviation 2.89 |
| LUMIGAN | Mean IOP at Each After Office Hour Evaluation Timepoint | 4 pm (20 hours post dose) | 17.08 millimeters mercury (mmHg) | Standard Deviation 2.808 |
| LUMIGAN | Mean IOP at Each After Office Hour Evaluation Timepoint | 6 pm (22 hours post dose) | 17.32 millimeters mercury (mmHg) | Standard Deviation 3.055 |