Glaucoma
Conditions
Keywords
Glaucoma
Brief summary
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Detailed description
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Interventions
Travoprost at 9 AM + Placebo & 9 PM
DRUGTimolol 0.5% Ophthalmic Solution (Timoptic)
Timolol in each eye, twice daily at 9 AM & 9 PM
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; * IOP=16-30mmHg * OH or OAG with visual filed abnormality: 1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p \<5% on the prepapillary diameter plot, one of which must have p \<1%, 2. Glaucoma Hemifield Test outside normal limits, 3. Corrected Pattern Standard Deviation with p \<5%
Exclusion criteria
* Previous damage of anterior chamber angle; * ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) \<1.0; * contact lens wearer; * severe central field loss; * uncontrolled cardiovascular, hepatic or renal disease; * any medication within past 1 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 9 AM | At Week 12 - At the 9 AM time point for the patient's worse eye. | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. |
| Week 12 - Mean IOP At 4 PM | At the 4 PM time point for the patient's worse eye. | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean IOP Change From Baseline at 9 AM | Baseline to Week 12 - at 9 AM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. |
| Mean IOP Change at 4 PM | Baseline to Week 12 - at 4 PM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. |
Countries
United States
Participant flow
Recruitment details
111 patients were enrolled in this study at 4 hospitals
Pre-assignment details
Eligibility patients were washed out for up to 4 weeks before randomization
Participants by arm
| Arm | Count |
|---|---|
| Travoprost 0.004% Travoprost at 9 AM + Placebo & 9 PM | 54 |
| Timolol 0.5% Timolol in each eye, twice daily at 9 AM & 9 PM | 57 |
| Total | 111 |
Baseline characteristics
| Characteristic | Travoprost 0.004% | Timolol 0.5% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 19 Participants | 25 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 48 Participants |
| Sex: Female, Male Male | 32 Participants | 31 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 57 |
| serious Total, serious adverse events | 0 / 54 | 0 / 57 |
Outcome results
Primary
Mean Intraocular Pressure (IOP) at 9 AM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time frame: At Week 12 - At the 9 AM time point for the patient's worse eye.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost 0.004% | Mean Intraocular Pressure (IOP) at 9 AM | 16.3 millimeters mercury (mmHg) | Standard Deviation 4.27 |
| Timolol 0.5% | Mean Intraocular Pressure (IOP) at 9 AM | 18.1 millimeters mercury (mmHg) | Standard Deviation 4.32 |
Primary
Week 12 - Mean IOP At 4 PM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time frame: At the 4 PM time point for the patient's worse eye.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost 0.004% | Week 12 - Mean IOP At 4 PM | 15.7 mmHg | Standard Deviation 3.16 |
| Timolol 0.5% | Week 12 - Mean IOP At 4 PM | 17.9 mmHg | Standard Deviation 4.02 |
Secondary
Mean IOP Change at 4 PM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time frame: Baseline to Week 12 - at 4 PM
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost 0.004% | Mean IOP Change at 4 PM | -5.3 mmHg | Standard Deviation 3.69 |
| Timolol 0.5% | Mean IOP Change at 4 PM | -3.7 mmHg | Standard Deviation 4.15 |
Secondary
Mean IOP Change From Baseline at 9 AM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time frame: Baseline to Week 12 - at 9 AM
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost 0.004% | Mean IOP Change From Baseline at 9 AM | -5.1 mmHg | Standard Deviation 4.35 |
| Timolol 0.5% | Mean IOP Change From Baseline at 9 AM | -4.4 mmHg | Standard Deviation 4.35 |