Trial Outcomes & Findings for Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) (NCT NCT01568008)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

933 participants

Primary outcome timeframe

Baseline

Results posted on

2013-09-20

Participant Flow

This was an observational study of participants who received Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) at a dose and frequency as determined by the physician prior to entry into the study.

Participant milestones

Participant milestones
Measure	All Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Overall Study STARTED	933
Overall Study COMPLETED	699
Overall Study NOT COMPLETED	234

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=933 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Age Continuous	65.40 Years STANDARD_DEVIATION 11.88 • n=5 Participants
Sex/Gender, Customized Male	442 Participants n=5 Participants
Sex/Gender, Customized Female	480 Participants n=5 Participants
Sex/Gender, Customized Missing data	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All patients with complete data available for IOP.

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

Outcome measures

Outcome measures
Measure	All Participants n=889 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Intraocular Pressure (IOP) at Baseline Right Eye (n=885)	22.04 mm Hg Standard Deviation 5.17
Intraocular Pressure (IOP) at Baseline Left Eye	22.07 mm Hg Standard Deviation 5.12

PRIMARY outcome

Timeframe: Week 12

Population: All patients with complete data available for IOP.

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.

Outcome measures

Outcome measures
Measure	All Participants n=889 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Intraocular Pressure (IOP) at Week 12 Right Eye (n=885)	16.94 mm Hg Standard Deviation 3.88
Intraocular Pressure (IOP) at Week 12 Left Eye	17.02 mm Hg Standard Deviation 4.15

SECONDARY outcome

Timeframe: 12 weeks

Population: All patients with data available for this outcome measure.

Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.

Outcome measures

Outcome measures
Measure	All Participants n=888 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Patient Assessment of Treatment Tolerability Using a 4-Point Scale Very good	460 Participants
Patient Assessment of Treatment Tolerability Using a 4-Point Scale Good	317 Participants
Patient Assessment of Treatment Tolerability Using a 4-Point Scale Moderate	61 Participants
Patient Assessment of Treatment Tolerability Using a 4-Point Scale Poor	50 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: All patients with data available for this outcome measure.

The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.

Outcome measures

Outcome measures
Measure	All Participants n=893 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Physician Assessment of Treatment Tolerability Using a 4-Point Scale Very good	489 Participants
Physician Assessment of Treatment Tolerability Using a 4-Point Scale Good	331 Participants
Physician Assessment of Treatment Tolerability Using a 4-Point Scale Moderate	49 Participants
Physician Assessment of Treatment Tolerability Using a 4-Point Scale Poor	24 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: All patients with data available for this outcome measure.

The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.

Outcome measures

Outcome measures
Measure	All Participants n=87 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Physician Reported Reasons for Treatment Discontinuation Unacceptable ocular tolerability	46 Participants
Physician Reported Reasons for Treatment Discontinuation Insufficient IOP control	20 Participants
Physician Reported Reasons for Treatment Discontinuation Patient lost to follow up	11 Participants
Physician Reported Reasons for Treatment Discontinuation Patient decision to withdraw from study	8 Participants
Physician Reported Reasons for Treatment Discontinuation Physician decision to withdraw patient from study	6 Participants
Physician Reported Reasons for Treatment Discontinuation Other reason	6 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: All patients with data available for this outcome measure.

The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?

Outcome measures

Outcome measures
Measure	All Participants n=862 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Number of Patients Continuing Treatment After 12 Weeks	755 Participants

Adverse Events

All Participants

Serious events: 7 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=933 participants at risk Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Eye disorders Ocular hyperaemia	0.32% 3/933
Eye disorders Vein disorder	0.11% 1/933
Eye disorders Eye irritation	0.11% 1/933
Eye disorders Dry eye	0.11% 1/933
Psychiatric disorders Nightmare	0.21% 2/933

Other adverse events

Other adverse events
Measure	All Participants n=933 participants at risk Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Eye disorders Ocular hyperaemia	5.7% 53/933

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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