Trial Outcomes & Findings for A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension (NCT NCT01830140)

Results Overview

Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

466 participants

Primary outcome timeframe

Baseline, 6 Weeks

Results posted on

2015-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Bimatoprost 0.01% Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Overall Study STARTED	233	233
Overall Study COMPLETED	226	229
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimatoprost 0.01% n=233 Participants Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% n=233 Participants Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.	Total n=466 Participants Total of all reporting groups
Age, Customized < 45 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Customized Between 45 and 65 years	91 Participants n=5 Participants	97 Participants n=7 Participants	188 Participants n=5 Participants
Age, Customized ≥65 years	136 Participants n=5 Participants	129 Participants n=7 Participants	265 Participants n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	158 Participants n=7 Participants	299 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	75 Participants n=7 Participants	167 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 Weeks

Population: Intent-to-Treat: all randomized patients

Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.01% n=233 Participants Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% n=233 Participants Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye	34.3 Percentage of Patients	39.1 Percentage of Patients

Adverse Events

Bimatoprost 0.01%

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

Bimatoprost 0.03%

Serious events: 2 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bimatoprost 0.01% n=233 participants at risk Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% n=233 participants at risk Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Musculoskeletal and connective tissue disorders Arthritis	0.43% 1/233	0.00% 0/233
Nervous system disorders Cerebrovascular Accident	0.43% 1/233	0.00% 0/233
Nervous system disorders Monoplegia	0.43% 1/233	0.00% 0/233
Hepatobiliary disorders Cholecystitis	0.00% 0/233	0.43% 1/233
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/92	1.3% 1/75

Other adverse events

Other adverse events
Measure	Bimatoprost 0.01% n=233 participants at risk Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% n=233 participants at risk Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Eye disorders Eye Pruritus	3.0% 7/233	5.6% 13/233
Eye disorders Conjunctival Hyperaemia	18.0% 42/233	22.7% 53/233

Additional Information

Therapeutic Area Head,

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