Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.
Interventions
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ocular hypertension or glaucoma in each eye * Requires intraocular pressure (IOP)-lowering therapy in both eyes * Best corrected visual acuity of 20/100 or better in each eye
Exclusion criteria
* Ocular seasonal allergies within 2 years * Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed) * Ocular surgery or laser within 3 months * Anticipated wearing of contact lenses during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events | 24 Months | An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia | 24 Months | An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported. |
Countries
Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.01% Ophthalmic Solution One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. | 400 |
| Bimatoprost 0.03% Ophthalmic Solution One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. | 398 |
| Total | 798 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 50 | 51 |
| Overall Study | Did not Receive Study Drug | 3 | 5 |
| Overall Study | Lack of Efficacy | 9 | 14 |
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Other Miscellaneous Reasons | 16 | 15 |
| Overall Study | Protocol Violation | 6 | 4 |
| Overall Study | Withdrawal by Subject | 12 | 9 |
Baseline characteristics
| Characteristic | Bimatoprost 0.01% Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 11 | 62.2 years STANDARD_DEVIATION 11.5 | 62.4 years STANDARD_DEVIATION 11.3 |
| Age, Customized < 45 years | 22 participants | 26 participants | 48 participants |
| Age, Customized ≥ 45 years to ≤ 65 years | 216 participants | 211 participants | 427 participants |
| Age, Customized > 65 years | 162 participants | 161 participants | 323 participants |
| Sex: Female, Male Female | 197 Participants | 187 Participants | 384 Participants |
| Sex: Female, Male Male | 203 Participants | 211 Participants | 414 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 167 / 400 | 186 / 398 |
| serious Total, serious adverse events | 45 / 400 | 40 / 398 |
Outcome results
Primary
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
Time frame: 24 Months
Population: Safety population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events | 33.3 percentage of participants |
| Bimatoprost 0.03% Ophthalmic Solution | Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events | 37.7 percentage of participants |
p-value: 0.14895% CI: [-11, 1.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.
Time frame: 24 Months
Population: Safety population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia | 26.0 percentage of participants |
| Bimatoprost 0.03% Ophthalmic Solution | Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia | 29.6 percentage of participants |