A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

Viatris

Status and phase: Completed; Phase 3

Conditions: Glaucoma

Treatments: Drug: latanoprost; Drug: Timolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716859

A6111137

Details and patient eligibility

About

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Enrollment: 139 patients

Sex: All

Ages: 36 weeks to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of 18 years of age or under
• Diagnosis of glaucoma
• IOP of 22 mmHg or above in at least 1 eye

Exclusion criteria

• Require surgery for acute angle closure
• Have had prior cyclodestructive procedures
• Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

139 participants in 2 patient groups

Timolol

Active Comparator group

Treatment:

Drug: Timolol

latanoprost

Experimental group

Treatment:

Drug: latanoprost