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

This study has been terminated.
(Study terminated due to corporate decision.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426113
First Posted: August 31, 2011
Last Update Posted: October 2, 2015
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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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) in the Study Eye [ Time Frame: Baseline, Week 6 ]
    IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.


Enrollment: 6
Study Start Date: September 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426113


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01426113     History of Changes
Other Study ID Numbers: 192024-056
First Submitted: August 29, 2011
First Posted: August 31, 2011
Results First Submitted: June 29, 2015
Results First Posted: October 2, 2015
Last Update Posted: October 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Bimatoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents