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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01830140
• Collaborator: (none)
• Enrollment: 466
• Locations: 2
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 233
• Patients Per Site Per Month: 23.3

Study Details

Study Description

Brief Summary

This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: Bimatoprost 0.01%; Drug: Bimatoprost 0.03%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 466 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimatoprost 0.01% Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Drug: Bimatoprost 0.01%; Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.; Other Names: LUMIGAN® 0.01%
Active Comparator: Bimatoprost 0.03% Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.	Drug: Bimatoprost 0.03%; Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.; Other Names: LUMIGAN® 0.03%

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye [Baseline, 6 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of glaucoma or ocular hypertension

Exclusion Criteria:

• Active ocular disease other than glaucoma or ocular hypertension

• Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Artesia	California	United States
2		El Paso	Texas	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01830140
• Other Study ID Numbers: 192024-081
• First Posted: Apr 12, 2013
• Last Update Posted: May 6, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Bimatoprost

Study Results

Participant Flow

Arm/Group Title	Bimatoprost 0.01%	Bimatoprost 0.03%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Period Title: Overall Study
STARTED	233	233
COMPLETED	226	229
NOT COMPLETED	7	4

Baseline Characteristics

Arm/Group Title	Bimatoprost 0.01%	Bimatoprost 0.03%	Total
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.	Total of all reporting groups
Overall Participants	233	233	466
Age, Customized (Number) [Number]
< 45 years	6 2.6%	7 3%	13 2.8%
Between 45 and 65 years	91 39.1%	97 41.6%	188 40.3%
≥65 years	136 58.4%	129 55.4%	265 56.9%
Sex: Female, Male (Count of Participants)
Female	141 60.5%	158 67.8%	299 64.2%
Male	92 39.5%	75 32.2%	167 35.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
Description	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.
Time Frame	Baseline, 6 Weeks

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all randomized patients

Arm/Group Title	Bimatoprost 0.01%	Bimatoprost 0.03%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.	Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Measure Participants	233	233
Number [Percentage of Patients]	34.3	39.1

Adverse Events

Arm/Group Title	Bimatoprost 0.01%		Bimatoprost 0.03%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.		Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
All Cause Mortality
	Bimatoprost 0.01%		Bimatoprost 0.03%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost 0.01%		Bimatoprost 0.03%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/233 (0.9%)		2/233 (0.9%)
Hepatobiliary disorders
Cholecystitis	0/233 (0%)		1/233 (0.4%)
Musculoskeletal and connective tissue disorders
Arthritis	1/233 (0.4%)		0/233 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer	0/92 (0%)		1/75 (1.3%)
Nervous system disorders
Cerebrovascular Accident	1/233 (0.4%)		0/233 (0%)
Monoplegia	1/233 (0.4%)		0/233 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost 0.01%		Bimatoprost 0.03%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/233 (21%)		66/233 (28.3%)
Eye disorders
Eye Pruritus	7/233 (3%)		13/233 (5.6%)
Conjunctival Hyperaemia	42/233 (18%)		53/233 (22.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.