Trial Outcomes & Findings for A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) (NCT NCT01632423)

NCT ID: NCT01632423

Last Updated: 2012-09-21

Results Overview

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

• Recruitment status: COMPLETED
• Target enrollment: 10337 participants
• Primary outcome timeframe: Baseline, 14 Weeks
• Results posted on: 2012-09-21

Participant Flow

Participant milestones

Measure	POAG or OHT Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Overall Study STARTED	10337
Overall Study COMPLETED	10091
Overall Study NOT COMPLETED	246

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Baseline characteristics by cohort

Measure	POAG or OHT n=10337 Participants Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Age Continuous	67.27 Years STANDARD_DEVIATION 12.33 • n=5 Participants
Sex/Gender, Customized Female	5978 Participants n=5 Participants
Sex/Gender, Customized Male	4307 Participants n=5 Participants
Sex/Gender, Customized Missing Data	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 14 Weeks

Population: All enrolled patients with complete data for this outcome measure

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Outcome measures

Measure	POAG or OHT n=10074 Participants Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Change From Baseline in Intraocular Pressure (IOP) Baseline - Right Eye (N=10062)	20.0 Millimeters of Mercury (mmHg) Interval 17.0 to 23.0
Change From Baseline in Intraocular Pressure (IOP) Change from Baseline at 14 Wks-Rt Eye (N=10062)	-4.0 Millimeters of Mercury (mmHg) Interval -5.0 to -3.0
Change From Baseline in Intraocular Pressure (IOP) Baseline - Left Eye (N=10074)	20.0 Millimeters of Mercury (mmHg) Interval 17.0 to 23.0
Change From Baseline in Intraocular Pressure (IOP) Change from Baseline at 14 Wks-Lft Eye (N=10074)	-4.0 Millimeters of Mercury (mmHg) Interval -5.0 to -3.0

SECONDARY outcome

Timeframe: 14 Weeks

Population: All enrolled patients with complete data for this outcome measure

Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

Outcome measures

Measure	POAG or OHT n=9982 Participants Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Patient Assessment of Tolerability Using a 4-Point Scale	9227 Participants

SECONDARY outcome

Timeframe: 14 Weeks

Population: All enrolled patients with complete data for this outcome measure

Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

Outcome measures

Measure	POAG or OHT n=10062 Participants Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Physician Assessment of Tolerability Using a 4-Point Scale	9571 Participants

SECONDARY outcome

Timeframe: 14 Weeks

Population: All enrolled patients with complete data for this outcome measure

Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.

Outcome measures

Measure	POAG or OHT n=9459 Participants Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks	642 Participants

SECONDARY outcome

Timeframe: 14 Weeks

Population: All enrolled patients with complete data for this outcome measure

Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.

Outcome measures

Measure	POAG or OHT n=10008 Participants Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Patients Who Will Continue Use of Lumigan® After 14 Weeks	9121 Participants

Adverse Events

POAG or OHT

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	POAG or OHT n=10337 participants at risk Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.01% 1/10337
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 1/10337

Other adverse events

Adverse event data not reported

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