Trial Outcomes & Findings for A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension (NCT NCT02061683)

Results Overview

IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

263 participants

Primary outcome timeframe

Month 3

Results posted on

2019-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Bimatoprost 0.03% Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Overall Study STARTED	263
Overall Study COMPLETED	203
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimatoprost 0.03% n=263 Participants Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Age, Continuous	48.7 Years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants
Sex: Female, Male Male	155 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3

Population: All enrolled patients with data available for analysis

IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% n=240 Participants Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Intraocular Pressure (IOP) in the Study Eye Group A (N=89)	16.5 Millimeters of Mercury (mmHg) Standard Deviation 3.4
Intraocular Pressure (IOP) in the Study Eye Group B (N=33)	16.7 Millimeters of Mercury (mmHg) Standard Deviation 3.3
Intraocular Pressure (IOP) in the Study Eye Group C (N=67)	15.7 Millimeters of Mercury (mmHg) Standard Deviation 2.6
Intraocular Pressure (IOP) in the Study Eye Group D (N=18)	16.1 Millimeters of Mercury (mmHg) Standard Deviation 3.5
Intraocular Pressure (IOP) in the Study Eye Group E (N=33)	17.2 Millimeters of Mercury (mmHg) Standard Deviation 4.4

SECONDARY outcome

Timeframe: 3 Months

Population: Safety population defined as all enrolled patients who completed at least 1 follow-up visit

Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% n=250 Participants Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Percentage of Patients With an Adverse Event of Conjunctival Hyperemia	76.0 Percentage of Patients

Adverse Events

Bimatoprost 0.03%

Serious events: 0 serious events

Other events: 229 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bimatoprost 0.03% n=250 participants at risk Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Eye disorders Eyelash growth	9.2% 23/250 The safety population was used to assess adverse events (AEs) and serious adverse events (SAEs), and was defined as all enrolled patients who completed at least 1 follow-up visit.
Skin and subcutaneous tissue disorders Skin pigmentation	6.4% 16/250 The safety population was used to assess adverse events (AEs) and serious adverse events (SAEs), and was defined as all enrolled patients who completed at least 1 follow-up visit.
Eye disorders Conjunctival Hyperemia	76.0% 190/250 The safety population was used to assess adverse events (AEs) and serious adverse events (SAEs), and was defined as all enrolled patients who completed at least 1 follow-up visit.

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 of at least 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