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

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ClinicalTrials.gov Identifier: NCT01830140
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions Drug: Bimatoprost 0.01%
Drug: Bimatoprost 0.03%
Enrollment 466

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost 0.01% Bimatoprost 0.03%
Hide 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
Arm/Group Title Bimatoprost 0.01% Bimatoprost 0.03% Total
Hide 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 Number of Baseline Participants 233 233 466
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 233 participants 233 participants 466 participants
< 45 years 6 7 13
Between 45 and 65 years 91 97 188
≥65 years 136 129 265
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 233 participants 466 participants
Female
141
  60.5%
158
  67.8%
299
  64.2%
Male
92
  39.5%
75
  32.2%
167
  35.8%
1.Primary Outcome
Title Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title Bimatoprost 0.01% Bimatoprost 0.03%
Hide 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.
Overall Number of Participants Analyzed 233 233
Measure Type: Number
Unit of Measure: Percentage of Patients
34.3 39.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bimatoprost 0.01% Bimatoprost 0.03%
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bimatoprost 0.01% Bimatoprost 0.03%
Affected / at Risk (%) Affected / at Risk (%)
Total   2/233 (0.86%)   2/233 (0.86%) 
Hepatobiliary disorders     
Cholecystitis  1  0/233 (0.00%)  1/233 (0.43%) 
Musculoskeletal and connective tissue disorders     
Arthritis * 1  1/233 (0.43%)  0/233 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate Cancer  1  0/92 (0.00%)  1/75 (1.33%) 
Nervous system disorders     
Cerebrovascular Accident  1  1/233 (0.43%)  0/233 (0.00%) 
Monoplegia * 1  1/233 (0.43%)  0/233 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimatoprost 0.01% Bimatoprost 0.03%
Affected / at Risk (%) Affected / at Risk (%)
Total   49/233 (21.03%)   66/233 (28.33%) 
Eye disorders     
Eye Pruritus * 1  7/233 (3.00%)  13/233 (5.58%) 
Conjunctival Hyperaemia  1  42/233 (18.03%)  53/233 (22.75%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01830140     History of Changes
Other Study ID Numbers: 192024-081
First Submitted: April 10, 2013
First Posted: April 12, 2013
Results First Submitted: April 21, 2015
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015