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

NCT ID: NCT01658839

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-07-31

Brief 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.

Conditions

Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Travoprost

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

Group Type: EXPERIMENTAL

Travoprost ophthalmic solution, 0.004% (new formulation)

Intervention Type: DRUG

Travoprost ophthalmic solution, 0.004%, new formulation

Interventions

Travoprost ophthalmic solution, 0.004% (new formulation)

Travoprost ophthalmic solution, 0.004%, new formulation

Intervention Type: DRUG

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.

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Subha Venkataraman

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

2012-001640-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C-12-009

Identifier Type: -

Identifier Source: org_study_id