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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01426113
• Date of registration: 29/08/2011
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
• Date of first enrolment: September 2011
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01426113
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France, Italy, Korea, Republic of, Philippines, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Allergan

Key inclusion & exclusion 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)



Age minimum: 2 Months
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Glaucoma

Intervention(s)

Drug: bimatoprost ophthalmic solution formulation A

Drug: timolol ophthalmic solution

Drug: bimatoprost vehicle

Primary Outcome(s)

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye [Time Frame: Baseline, Week 6]

Secondary ID(s)

192024-056

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/10/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01426113