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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01830140
First received: April 10, 2013
Last updated: July 9, 2014
Last verified: July 2014

April 10, 2013
July 9, 2014
July 2013
May 2014   (final data collection date for primary outcome measure)
Percentage of Patients with an Increase in Macroscopic Conjunctival Hyperemia [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01830140 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01830140
192024-081
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2014

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