A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
This study is currently recruiting participants.
Verified January 2013 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01426113
First received: August 29, 2011
Last updated: January 21, 2013
Last verified: January 2013
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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, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of Patients with a 15% Decrease in Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 84 |
| 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
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 12 weeks.
|
Drug: bimatoprost ophthalmic solution formulation A
1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 12 weeks.
Drug: bimatoprost vehicle
1 drop bimatoprost vehicle in the affected eye(s) in the morning for 12 weeks.
|
|
Active Comparator: timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and 1 drop timolol ophthalmic solution in the affected eye(s) in the evening for 12 weeks.
|
Drug: timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and 1 drop timolol ophthalmic solution in the affected eye(s) in the 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426113
Contacts
| Contact: Allergan Inc. | clinicaltrials@allergan.com |
Locations
| United States, New York | |
| Recruiting | |
| 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 | |
| Not yet recruiting | |
| Makati, 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: | January 21, 2013 |
| 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 May 19, 2013