A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
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| ClinicalTrials.gov Identifier: NCT01426113 |
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Recruitment Status :
Terminated
(Study terminated due to corporate decision.)
First Posted : August 31, 2011
Results First Posted : October 2, 2015
Last Update Posted : October 2, 2015
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Glaucoma | Drug: bimatoprost ophthalmic solution formulation A Drug: timolol ophthalmic solution Drug: bimatoprost vehicle | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Study Start Date : | September 2011 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | October 2014 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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Active Comparator: timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
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Drug: timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. |
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.
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| 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)
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 |
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01426113 |
| Other Study ID Numbers: |
192024-056 |
| First Posted: | August 31, 2011 Key Record Dates |
| Results First Posted: | October 2, 2015 |
| Last Update Posted: | October 2, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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Glaucoma Ocular Hypertension Eye Diseases Timolol Bimatoprost Pharmaceutical Solutions Ophthalmic Solutions Adrenergic beta-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents |