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

Inclusion Criteria:

- Less than 18 years of age at the time of screening.

- 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.

- 1 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.

- Other protocol-defined exclusion criteria may apply.