A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01426113
First received: August 29, 2011
Last updated: June 12, 2014
Last verified: June 2014

August 29, 2011
June 12, 2014
September 2011
March 2015   (final data collection date for primary outcome measure)
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01426113 on ClinicalTrials.gov Archive Site
Percentage of Patients with a 15% Decrease in IOP [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Percentage of Patients with a 15% Decrease in Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Not Provided

The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Glaucoma
  • Drug: bimatoprost ophthalmic solution formulation A
    1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks.
  • Drug: timolol ophthalmic solution
    1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
  • Drug: bimatoprost vehicle
    1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.
  • Experimental: bimatoprost ophthalmic solution formulation A and vehicle
    1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
    Interventions:
    • Drug: bimatoprost ophthalmic solution formulation A
    • Drug: bimatoprost vehicle
  • Active Comparator: timolol ophthalmic solution
    1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
    Intervention: Drug: timolol ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of congenital, juvenile glaucoma
  • Requires treatment with IOP-lowering medication in one or both eyes

Exclusion Criteria:

  • Surgical intervention is indicated or planned to lower IOP
  • Abnormally low body weight (below 5th percentile)
  • Any active eye infection or disease
  • Anticipated use of contact lenses during the study
  • Topical ocular steroid use within 2 months
  • History of ocular trauma in either eye
  • Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)
Both
2 Months to 17 Years
No
Contact: Allergan Inc. clinicaltrials@allergan.com
Italy,   United States,   France,   United Kingdom,   Korea, Republic of,   Philippines,   Spain,   Taiwan
 
NCT01426113
192024-056
Yes
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
June 2014

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