Glaucoma, Ocular Hypertension
Conditions
Brief summary
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%
Interventions
bimatoprost 0.03% 1 drop nightly for 3 months
travoprost 0.004% 1 drop nightly for 3 months
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Glaucoma or ocular hypertension in both eyes * Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering * Best-corrected visual acuity of 20/100 or better in each eye * Visual field within 6 months of study entry
Exclusion criteria
* Secondary glaucoma * Active intraocular inflammation or macular edema * Intraocular surgery or laser surgery within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | Month 3 | Intraocular Pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability - Conjunctival Hyperemia | Month 3 | Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost bimatoprost 0.03% 1 drop nightly for 3 months | 131 |
| Travoprost travoprost 0.004% 1 drop nightly for 3 months | 135 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Bimatoprost | Travoprost | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 12.3 | 62.7 years STANDARD_DEVIATION 12.4 | 63.0 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 131 participants | 135 participants | 266 participants |
| Sex: Female, Male Female | 81 Participants | 66 Participants | 147 Participants |
| Sex: Female, Male Male | 50 Participants | 69 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 131 | 22 / 133 |
| serious Total, serious adverse events | 1 / 131 | 0 / 133 |
Outcome results
Primary
Intraocular Pressure (IOP)
Intraocular Pressure
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost | Intraocular Pressure (IOP) | 17 mm Hg | Standard Deviation 3.1 |
| Travoprost | Intraocular Pressure (IOP) | 17.5 mm Hg | Standard Deviation 2.6 |
p-value: 0.024ANCOVA
Secondary
Tolerability - Conjunctival Hyperemia
Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)
Time frame: Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost | Tolerability - Conjunctival Hyperemia | 15 participants |
| Travoprost | Tolerability - Conjunctival Hyperemia | 22 participants |