Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost

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.