Conditions: Childhood Glaucoma
Keywords: Intraocular pressure Latanoprost Dorzolamide
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 37
Healthy volunteers: no

Brief summary:
Objectives:

The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to surgical procedures. Safety will be assessed, too.In the first version of the protocol 96 eyes were forecasted to complete the enrolment. The protocol was then amended and now to complete the study 68 eyes should be included. This number of eyes could be achieved by recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for the study.

Detailed description:
Study design:

Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as much as possible to current clinical practice, the presence of a control arm is not planned. Due to the non-comparative nature of the study, no blinding of treatment is planned.

Arms:
arm 1: According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.

Interventions: intervention 1: Latanoprost, Dorzolamide
Intervention descriptions: intervention 1: * Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)
* Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost

Protocol document: