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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830140
First Posted: April 12, 2013
Last Update Posted: May 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
April 10, 2013
April 12, 2013
April 21, 2015
May 6, 2015
May 6, 2015
July 2013
May 2014   (Final data collection date for primary outcome measure)
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye [ Time Frame: 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.
Percentage of Patients with an Increase in Macroscopic Conjunctival Hyperemia [ Time Frame: Baseline, 6 Weeks ]
Complete list of historical versions of study NCT01830140 on ClinicalTrials.gov Archive Site
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A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Not Provided
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: Bimatoprost 0.01%
    Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
    Other Name: LUMIGAN® 0.01%
  • Drug: Bimatoprost 0.03%
    Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
    Other Name: LUMIGAN® 0.03%
  • Experimental: Bimatoprost 0.01%
    Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
    Intervention: Drug: Bimatoprost 0.01%
  • Active Comparator: Bimatoprost 0.03%
    Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
    Intervention: Drug: Bimatoprost 0.03%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
466
May 2014
May 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01830140
192024-081
No
Not Provided
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Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP