Trial Outcomes & Findings for A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension (NCT NCT01646151)

NCT ID: NCT01646151

Last Updated: 2014-06-13

Results Overview

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.

• Recruitment status: COMPLETED
• Target enrollment: 2580 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2014-06-13

Participant Flow

Participant milestones

Measure	Bimatoprost Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Overall Study STARTED	2580
Overall Study COMPLETED	2410
Overall Study NOT COMPLETED	170

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Measure	Bimatoprost n=2580 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Age, Customized <18 years	0 Participants n=5 Participants
Age, Customized 18 to 30 years	12 Participants n=5 Participants
Age, Customized 31 to 40 years	20 Participants n=5 Participants
Age, Customized 41 to 50 years	178 Participants n=5 Participants
Age, Customized 51 to 60 years	403 Participants n=5 Participants
Age, Customized 61 to 70 years	695 Participants n=5 Participants
Age, Customized 71 to 80 years	883 Participants n=5 Participants
Age, Customized 81 to 90 years	342 Participants n=5 Participants
Age, Customized >=91 years	19 Participants n=5 Participants
Age, Customized Missing	28 Participants n=5 Participants
Sex/Gender, Customized Female	1454 Participants n=5 Participants
Sex/Gender, Customized Male	1115 Participants n=5 Participants
Sex/Gender, Customized Missing	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All patients with data for this outcome measure

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.

Outcome measures

Measure	Bimatoprost n=2099 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Intraocular Pressure (IOP) at Baseline Right Eye	20.51 Millimeters of Mercury (mmHg) Standard Deviation 4.32
Intraocular Pressure (IOP) at Baseline Left Eye (n=2091)	20.65 Millimeters of Mercury (mmHg) Standard Deviation 4.54

PRIMARY outcome

Timeframe: Week 12

Population: All patients with data for this outcome measure

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.

Outcome measures

Measure	Bimatoprost n=2099 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
IOP at Week 12 Right Eye	15.78 Millimeters of Mercury (mmHg) Standard Deviation 2.85
IOP at Week 12 Left Eye (n=2091)	15.87 Millimeters of Mercury (mmHg) Standard Deviation 3.19

SECONDARY outcome

Timeframe: Week 12

Population: All patients with data for this outcome measure

IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.

Outcome measures

Measure	Bimatoprost n=2671 Eyes Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Physician Evaluation of IOP Lowering in the Study Eye(s) IOP lower than target	622 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) Target IOP reached	1173 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) IOP decreased but target not reached	467 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) IOP increased	85 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) No change	119 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) Data Missing	205 Eyes

SECONDARY outcome

Timeframe: Week 12

Population: All patients with data for this outcome measure

Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

Outcome measures

Measure	Bimatoprost n=2347 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Patient Assessment of Tolerability on a 4-Point Scale Very Good	1127 Patients
Patient Assessment of Tolerability on a 4-Point Scale Good	1070 Patients
Patient Assessment of Tolerability on a 4-Point Scale Moderate	80 Patients
Patient Assessment of Tolerability on a 4-Point Scale Poor	70 Patients

SECONDARY outcome

Timeframe: Week 12

Population: All patients with data for this outcome measure

Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

Outcome measures

Measure	Bimatoprost n=2369 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Physician Assessment of Tolerability on a 4-Point Scale Moderate	74 Patients
Physician Assessment of Tolerability on a 4-Point Scale Very Good	1212 Patients
Physician Assessment of Tolerability on a 4-Point Scale Good	1059 Patients
Physician Assessment of Tolerability on a 4-Point Scale Poor	24 Patients

SECONDARY outcome

Timeframe: Week 12

Population: All patients with data for this outcome measure

Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.

Outcome measures

Measure	Bimatoprost n=2113 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Physician Assessment of Patient Compliance Compared to Previous Therapy Better	875 Patients
Physician Assessment of Patient Compliance Compared to Previous Therapy Equal	1151 Patients
Physician Assessment of Patient Compliance Compared to Previous Therapy Worse	51 Patients
Physician Assessment of Patient Compliance Compared to Previous Therapy Not Applicable	36 Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients

Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.

Outcome measures

Measure	Bimatoprost n=2580 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment	6.6 Percentage of Patients

SECONDARY outcome

Timeframe: Week 12

Population: All patients

Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.

Outcome measures

Measure	Bimatoprost n=2580 Participants Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops	85.8 Percentage of Patients

Adverse Events

Bimatoprost

Serious events: 0 serious events

Other events: 450 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bimatoprost n=2580 participants at risk Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Eye disorders Conjunctival Hyperaemia	11.3% 292/2580 All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Eye Irritation	6.1% 158/2580 All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs).

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

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