A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

Viatris

Status and phase: Completed; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: latanoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638742

A6111139

Details and patient eligibility

About

To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.

Full description

Pharmacokinetics and Safety

Enrollment: 47 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks.
• The pediatric subjects will be grouped by age (0 to <3 years, 3 to <12 years, 12 to 18 years).

Exclusion criteria

• Ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit.
• History of ocular trauma or surgery in either eye within 14-days of the screening visit.
• Use of continuous wear contact lenses.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

1

Experimental group

Treatment:

Drug: latanoprost