Glaucoma, Ocular Hypertension
Conditions
Brief summary
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
Interventions
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Sponsors
Allergan
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
* Diagnosis of glaucoma or ocular hypertension
Exclusion criteria
* Active ocular disease other than glaucoma or ocular hypertension * Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye | Baseline, 6 Weeks | Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.01% Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. | 233 |
| Bimatoprost 0.03% Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. | 233 |
| Total | 466 |
Baseline characteristics
| Characteristic | Bimatoprost 0.01% | Bimatoprost 0.03% | Total |
|---|---|---|---|
| Age, Customized < 45 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Customized ≥65 years | 136 Participants | 129 Participants | 265 Participants |
| Age, Customized Between 45 and 65 years | 91 Participants | 97 Participants | 188 Participants |
| Sex: Female, Male Female | 141 Participants | 158 Participants | 299 Participants |
| Sex: Female, Male Male | 92 Participants | 75 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 233 | 66 / 233 |
| serious Total, serious adverse events | 2 / 233 | 2 / 233 |
Outcome results
Primary
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.
Time frame: Baseline, 6 Weeks
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost 0.01% | Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye | 34.3 Percentage of Patients |
| Bimatoprost 0.03% | Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye | 39.1 Percentage of Patients |