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

Alcon

Status and phase: Completed; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost ophthalmic solution, 0.004% (new formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01658839

C-12-009

2012-001640-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 2 months to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Travoprost

Experimental group

Description:

Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days

Treatment:

Drug: Travoprost ophthalmic solution, 0.004% (new formulation)