Trial Outcomes & Findings for A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension (NCT NCT00538304)
NCT ID: NCT00538304
Last Updated: 2019-04-23
Results Overview
Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.
COMPLETED
PHASE2
222 participants
Baseline, Month 1
2019-04-23
Participant Flow
Participant milestones
| Measure |
Bimatoprost Eye Drops
Bimatoprost eye drops
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
71
|
|
Overall Study
COMPLETED
|
144
|
66
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Bimatoprost Eye Drops
n=151 Participants
Bimatoprost eye drops
|
Placebo
n=71 Participants
Placebo
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 years
|
9 participants
n=93 Participants
|
2 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Age, Customized
Between 45 and 65 years
|
66 participants
n=93 Participants
|
32 participants
n=4 Participants
|
98 participants
n=27 Participants
|
|
Age, Customized
> 65 years
|
76 participants
n=93 Participants
|
37 participants
n=4 Participants
|
113 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.
Outcome measures
| Measure |
Bimatoprost Eye Drops
n=147 Participants
Bimatoprost eye drops
|
Placebo
n=71 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
Baseline
|
0.32 Number on a scale (score)
Standard Deviation 0.280
|
0.30 Number on a scale (score)
Standard Deviation 0.288
|
|
Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
Month 1
|
0.18 Number on a scale (score)
Standard Deviation 0.456
|
0.02 Number on a scale (score)
Standard Deviation 0.321
|
SECONDARY outcome
Timeframe: Month 1Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Percentage of patients with a \>= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).
Outcome measures
| Measure |
Bimatoprost Eye Drops
n=147 Participants
Bimatoprost eye drops
|
Placebo
n=71 Participants
Placebo
|
|---|---|---|
|
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1
|
8.16 Percentage of Patients
|
1.41 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Month 1Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Outcome measures
| Measure |
Bimatoprost Eye Drops
n=147 Participants
Bimatoprost eye drops
|
Placebo
n=71 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
Baseline, 8AM
|
18.2 millimeters of mercury (mmHg)
Standard Deviation 3.13
|
18.0 millimeters of mercury (mmHg)
Standard Deviation 3.34
|
|
Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
Month 1, 8AM
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 2.64
|
3.6 millimeters of mercury (mmHg)
Standard Deviation 3.85
|
SECONDARY outcome
Timeframe: Month 1Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked "Overall, based on how well this drug lowered THIS patient's IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason.
Outcome measures
| Measure |
Bimatoprost Eye Drops
n=147 Participants
Bimatoprost eye drops
|
Placebo
n=71 Participants
Placebo
|
|---|---|---|
|
Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
|
85.7 Percentage of Physicians
|
39.5 Percentage of Physicians
|
SECONDARY outcome
Timeframe: Month 1Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked "Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason.
Outcome measures
| Measure |
Bimatoprost Eye Drops
n=147 Participants
Bimatoprost eye drops
|
Placebo
n=71 Participants
Placebo
|
|---|---|---|
|
Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
|
88.5 Percentage of Patients
|
52.9 Percentage of Patients
|
SECONDARY outcome
Timeframe: Month 1Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked "Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?". The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor's office told them to expect.
Outcome measures
| Measure |
Bimatoprost Eye Drops
n=147 Participants
Bimatoprost eye drops
|
Placebo
n=71 Participants
Placebo
|
|---|---|---|
|
Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1
|
95.1 Percentage of Patients
|
94.1 Percentage of Patients
|
Adverse Events
Bimatoprost Eye Drops
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bimatoprost Eye Drops
n=150 participants at risk
Bimatoprost eye drops
|
Placebo
n=71 participants at risk
Placebo
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
6.7%
10/150
The safety population consisted of all patients who were randomized, received at least 1 dose of masked study medication and had at least 1 post-baseline visit.
|
2.8%
2/71
The safety population consisted of all patients who were randomized, received at least 1 dose of masked study medication and had at least 1 post-baseline visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER