Trial Outcomes & Findings for A Study of Bimatoprost 0.01% in the Clinical Setting (NCT NCT01814761)
NCT ID: NCT01814761
Last Updated: 2015-10-26
Results Overview
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.
Recruitment status
COMPLETED
Target enrollment
312 participants
Primary outcome timeframe
12 Weeks
Results posted on
2015-10-26
Participant Flow
Participant milestones
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
270
|
|
Overall Study
COMPLETED
|
34
|
240
|
|
Overall Study
NOT COMPLETED
|
8
|
30
|
Reasons for withdrawal
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Overall Study
Other Reasons
|
1
|
10
|
|
Overall Study
Ocular Adverse Event
|
6
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
Baseline Characteristics
A Study of Bimatoprost 0.01% in the Clinical Setting
Baseline characteristics by cohort
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
n=42 Participants
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
n=270 Participants
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 13.65 • n=39 Participants
|
53.4 Years
STANDARD_DEVIATION 14.45 • n=41 Participants
|
53.3 Years
STANDARD_DEVIATION 14.33 • n=35 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
114 Participants
n=41 Participants
|
134 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
156 Participants
n=41 Participants
|
178 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.
Outcome measures
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
n=42 Participants
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
n=270 Participants
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
None
|
7 Patients
|
36 Patients
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Trace
|
10 Patients
|
50 Patients
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Mild
|
12 Patients
|
84 Patients
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Moderate
|
5 Patients
|
59 Patients
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Severe
|
0 Patients
|
11 Patients
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Missing
|
8 Patients
|
30 Patients
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
Outcome measures
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
n=42 Participants
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
n=270 Participants
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Baseline
|
18.0 Millimeters of Mercury (mmHg)
Standard Deviation 3.82
|
17.8 Millimeters of Mercury (mmHg)
Standard Deviation 3.89
|
|
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Week 12 (N=34, 240)
|
-3.6 Millimeters of Mercury (mmHg)
Standard Deviation 3.55
|
-2.6 Millimeters of Mercury (mmHg)
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.
Outcome measures
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
n=42 Participants
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
n=270 Participants
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Percentage of Patients Who Discontinue Due to an Adverse Event
|
14.3 Percentage of Patients
|
5.6 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).
Outcome measures
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
n=34 Participants
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
n=240 Participants
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Overall Percent Change From Baseline in IOP
|
-19.25 Percentage Change
Interval -24.8 to -13.7
|
-13.26 Percentage Change
Interval -15.4 to -11.2
|
Adverse Events
Pts With POAG or OH (Previously Treatment Naive)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Pts With POAG or OH (Switched Monotherapy)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
n=42 participants at risk
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
n=270 participants at risk
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/42
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
0.37%
1/270
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/42
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
0.37%
1/270
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
|
Injury, poisoning and procedural complications
Traumatic Intracranial Haemorrhage
|
2.4%
1/42
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
0.00%
0/270
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
Other adverse events
| Measure |
Pts With POAG or OH (Previously Treatment Naive)
n=42 participants at risk
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
Pts With POAG or OH (Switched Monotherapy)
n=270 participants at risk
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
|
|---|---|---|
|
Eye disorders
Ocular Hyperaemia
|
16.7%
7/42
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
5.2%
14/270
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
|
Eye disorders
Dry Eye
|
7.1%
3/42
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
0.74%
2/270
The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
|
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