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Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298700
First Posted: February 18, 2011
Last Update Posted: December 12, 2016
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
February 16, 2011
February 18, 2011
December 12, 2016
April 2011
December 2016   (Final data collection date for primary outcome measure)
Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events [ Time Frame: Month 24 ]
Same as current
Complete list of historical versions of study NCT01298700 on ClinicalTrials.gov Archive Site
Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia" [ Time Frame: Month 24 ]
Same as current
Not Provided
Not Provided
 
Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension
This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: bimatoprost 0.01% ophthalmic solution
    One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
    Other Names:
    • LUMIGAN® 0.01%
    • LUMIGAN 0.1 mg/ml
  • Drug: bimatoprost 0.03% ophthalmic solution
    One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
    Other Names:
    • LUMIGAN® 0.03%
    • LUMIGAN 0.3 mg/ml
  • Active Comparator: bimatoprost 0.01% ophthalmic solution
    One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
    Intervention: Drug: bimatoprost 0.01% ophthalmic solution
  • Active Comparator: bimatoprost 0.03% ophthalmic solution
    One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
    Intervention: Drug: bimatoprost 0.03% ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
807
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ocular hypertension or glaucoma in each eye
  • Requires intraocular pressure (IOP)-lowering therapy in both eyes
  • Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

  • Ocular seasonal allergies within 2 years
  • Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
  • Ocular surgery or laser within 3 months
  • Anticipated wearing of contact lenses during the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   France,   Germany,   Hungary,   Israel,   Italy,   Poland,   Spain,   United Kingdom
 
 
NCT01298700
192024-054
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Kristopher Hansen Allergan
Allergan
December 2016

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