Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01298700
First received: February 16, 2011
Last updated: January 22, 2015
Last verified: January 2015

February 16, 2011
January 22, 2015
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Not Provided

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Active, not recruiting
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
Both
18 Years and older
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
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
January 2015

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