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
  Purpose

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.


Condition Intervention Phase
Glaucoma
Drug: bimatoprost ophthalmic solution formulation A
Drug: timolol ophthalmic solution
Drug: bimatoprost vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patients with a 15% Decrease in IOP [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
Active Comparator: timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
Drug: timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

  Eligibility

Ages Eligible for Study:   2 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426113

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, Kentucky
Recruiting
Louisville, Kentucky, United States
United States, New York
Withdrawn
Bronx, New York, United States
France
Recruiting
Amiens, France
Withdrawn
Lyon, France
Italy
Recruiting
Milan, Italy
Recruiting
Parma, Italy
Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Philippines
Recruiting
Makati, Philippines
Recruiting
Taguig, Philippines
Spain
Withdrawn
Torrevieja, Spain
Taiwan
Recruiting
Taipei, Taiwan
United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01426113     History of Changes
Other Study ID Numbers: 192024-056
Study First Received: August 29, 2011
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Bimatoprost
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 22, 2014