Trial Outcomes & Findings for A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension (NCT NCT02020512)

Results Overview

IOP is a measurement 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 (worsening).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

87 participants

Primary outcome timeframe

Baseline, Week 5

Results posted on

2014-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	0.03% Bimatoprost 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Overall Study STARTED	87
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	0.03% Bimatoprost 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	3
Overall Study Protocol Violation	4

Baseline Characteristics

A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.03% Bimatoprost n=87 Participants 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Age, Continuous	47.3 Years STANDARD_DEVIATION 18.1 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 5

Population: Intent-to-Treat: all treated patients

IOP is a measurement 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 (worsening).

Outcome measures

Outcome measures
Measure	0.03% Bimatoprost n=87 Participants 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye Baseline	22.2 Millimeters of Mercury (mmHg) Standard Deviation 5.3
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye Change from Baseline at Week 5	-6.7 Millimeters of Mercury (mmHg) Standard Deviation 4.5

Adverse Events

0.03% Bimatoprost

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.03% Bimatoprost n=87 participants at risk 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Eye disorders Conjunctival Hyperemia	77.0% 67/87

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