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

Phase 2

Completed

Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Latanoprost, Dorzolamide	Latanoprost, Dorzolamide	According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Response	3 years	defined as those eyes in which the decrease of intraocular pressure (IOP) of at least 20% with respect to baseline assessment will be achieved and maintained during the 3-year period of study duration

Secondary Outcome Measures

Name	Time	Method
Time to Treatment Failure (TTF)	3 years	calculated as the time from the date of baseline visit to the date in which the medical treatment will be stopped, since IOP control will be considered not satisfactory
Number of Eyes With an Adverse Event (AE)	3 years	The occurrence of the following events will be monitored: growth of the eyelashes (hypertrichosis), changes iris colour, corneal epitheliopathy, allergic conjunctivitis, increase of central corneal thickness, non-serious and serious adverse event occurrence.

Locations (2): Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹
Brescia, Italy
A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
🇮🇹
Catania, Italy