Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Travoprost ophthalmic solution, 0.004% (new formulation)
Intervention description: Travoprost ophthalmic solution, 0.004%, new formulation
Intervention MeSH terms: Travoprost; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 2 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pediatric glaucoma; pediatric ocular hypertension; travoprost

Summary:

      The purpose of this study was to assess the safety and describe the steady-state plasma
      pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation)
      following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of glaucoma or ocular hypertension in at least 1 eye.

          -  Parent/legal guardian must provide informed consent, and children must agree to sign
             an approved assent form when applicable.

          -  Must agree to comply with the requirements of the study and must be accompanied by a
             parent/guardian.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Females of childbearing potential that are currently pregnant, have a positive result
             on a pregnancy test at the Screening Visit, intend to become pregnant during the study
             period, are breast feeding, or are not using birth control measures.

          -  One sighted eye or monocular, including patients who cannot be dosed in both eyes for
             any reason.

          -  History of chronic, recurrent or severe inflammatory eye disease.

          -  Ocular trauma requiring medical attention within the past 3 months prior to the
             Screening Visit.

          -  Ocular infection or ocular inflammation within the past 30 days prior to the Screening
             Visit.

          -  Clinically significant or progressive retinal disease such as retinal degeneration,
             diabetic retinopathy, or retinal detachment.

          -  Other severe ocular pathology (including severe dry eye), that in the opinion of the
             Investigator, would preclude the administration of a topical prostaglandin analogue.

          -  Intraocular surgery within the past 30 days prior to the Screening Visit.

          -  Any abnormality preventing reliable tonometry.

          -  Any other conditions including severe illness which would make the patient, in the
             opinion of the Investigator, unsuitable for the study.

          -  Hypersensitivity to prostaglandin analogues or to any component of the study
             medications in the opinion of the Investigator.

          -  Therapy with another investigational agent or device within 30 days prior to the
             Screening Visit.

          -  Body weight < 5kg.

          -  Other protocol-defined exclusion criteria may apply.