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

Study Identifier
192024-056
CT.gov Identifier
NCT01426113
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Glaucoma - Other
    • Study Drug
  • bimatoprost ophthalmic solution formulation A
  • timolol ophthalmic solution
  • bimatoprost vehicle
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    2 Months - 17 Years
    Inclusion and 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)

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Louisville, Kentucky, United States
    Status
    Not applicable
    Location
    Amiens, France
    Status
    Not applicable
    Location
    Milan, Italy
    Status
    Not applicable
    Location
    Parma, Italy
    Status
    Not applicable
    Location
    City of Taguig, Philippines
    Status
    Not applicable
    Location
    Makati, Philippines
    Status
    Not applicable
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