Trial Outcomes & Findings for Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension (NCT NCT00541242)
NCT ID: NCT00541242
Last Updated: 2011-10-27
Results Overview
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. 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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
586 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2011-10-27
Participant Flow
Participant milestones
| Measure |
Bimatoprost 0.03% Eye Drops
Bimatoprost 0.03% eye drops
|
Latanoprost 0.005% Eye Drops
Latanoprost 0.005% eye drops
|
|---|---|---|
|
Treatment Period 1
STARTED
|
0
|
586
|
|
Treatment Period 1
COMPLETED
|
0
|
586
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
270
|
273
|
|
Treatment Period 2
COMPLETED
|
261
|
266
|
|
Treatment Period 2
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Bimatoprost 0.03% Eye Drops
n=270 Participants
Bimatoprost 0.03% eye drops
|
Latanoprost 0.005% Eye Drops
n=273 Participants
Latanoprost 0.005% eye drops
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 years
|
9 participants
n=5 Participants
|
16 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 65 years
|
111 participants
n=5 Participants
|
120 participants
n=7 Participants
|
231 participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
150 participants
n=5 Participants
|
137 participants
n=7 Participants
|
287 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. 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 0.03% Eye Drops
n=270 Participants
Bimatoprost 0.03% eye drops
|
Latanoprost 0.005% Eye Drops
n=272 Participants
Latanoprost 0.005% eye drops
|
|---|---|---|
|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Week 12
|
-5.64 millimeters of mercury (mmHg)
Standard Deviation 2.968
|
-4.89 millimeters of mercury (mmHg)
Standard Deviation 2.872
|
|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Baseline
|
21.90 millimeters of mercury (mmHg)
Standard Deviation 3.656
|
22.16 millimeters of mercury (mmHg)
Standard Deviation 3.569
|
PRIMARY outcome
Timeframe: Baseline, Week 18Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. 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 0.03% Eye Drops
n=270 Participants
Bimatoprost 0.03% eye drops
|
Latanoprost 0.005% Eye Drops
n=272 Participants
Latanoprost 0.005% eye drops
|
|---|---|---|
|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Baseline
|
21.90 millimeters of mercury (mmHg)
Standard Deviation 3.656
|
22.16 millimeters of mercury (mmHg)
Standard Deviation 3.569
|
|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Week 18
|
-5.77 millimeters of mercury (mmHg)
Standard Deviation 3.023
|
-5.09 millimeters of mercury (mmHg)
Standard Deviation 2.709
|
Adverse Events
Bimatoprost 0.03% Eye Drops
Serious events: 4 serious events
Other events: 59 other events
Deaths: 0 deaths
Latanoprost 0.005% Eye Drops
Serious events: 11 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost 0.03% Eye Drops
n=269 participants at risk
Bimatoprost 0.03% eye drops
|
Latanoprost 0.005% Eye Drops
n=586 participants at risk
Latanoprost 0.005% eye drops
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
1/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.00%
0/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.37%
1/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.00%
0/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.37%
1/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.00%
0/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Infections and infestations
Pneumonia
|
0.37%
1/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.34%
2/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Vascular disorders
Aortic anyeurysm
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
|
Reproductive system and breast disorders
Prostamegaly
|
0.00%
0/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
0.17%
1/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
Other adverse events
| Measure |
Bimatoprost 0.03% Eye Drops
n=269 participants at risk
Bimatoprost 0.03% eye drops
|
Latanoprost 0.005% Eye Drops
n=586 participants at risk
Latanoprost 0.005% eye drops
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
21.9%
59/269
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
15.2%
89/586
SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
|
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