Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status and phase

Completed

Phase 2

Conditions

Childhood Glaucoma

Treatments

Drug: Latanoprost, Dorzolamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01527682

2008-004763-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

1 month to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children of either sexes, aged 0-12 years
Diagnosis of mono- or bilateral primary congenital glaucoma
IOP greater than or equal to 22 mmHg and lower than 27 mmHg
Only one previous ocular hypotensive surgical procedure for treatment of glaucoma among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin C) (only for medical treatment at least one month before)
Parent informed consent to data processing (at registration)
Parent informed consent before any study procedure

Exclusion criteria

Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma, steroid-induced glaucoma, etc.)
Presence of concomitant abnormalities of the anterior segment of the eye (cataract, iridocorneal dysgenesia, congenital uveal ectropion uvea, etc.)
Previous treatment with the study drugs
Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease, renal failure, etc.) that needs treatment with drugs, that could influence IOP (steroids, beta-blockers, angiotensin-converting-enzyme inhibitor -inhibitors diuretics, etc.)
Abnormalities of the cornea that could influence IOP readings (marked cornea edema)