Clinical trial NCT01527682: Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
Official title: Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Childhood Glaucoma
Keywords: Intraocular pressure
Latanoprost
Dorzolamide
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 37
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Eyes With Response
timeFrame: 3 years
Secondary outcomes:
measure: Time to Treatment Failure (TTF)
timeFrame: 3 years
measure: Number of Eyes With an Adverse Event (AE)
timeFrame: 3 years
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Catania
country: Italy
facility: A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
Study officials:
affiliation: Università di Brescia, Spedali Civili di Brescia
name: Luciano Quaranta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uva MG, Avitabile T, Reibaldi M, Bucolo C, Drago F, Quaranta L, Lionetti E, Longo A. Long-term efficacy of latanoprost in primary congenital glaucoma. Eye (Lond). 2014 Jan;28(1):53-7. doi: 10.1038/eye.2013.232. Epub 2013 Oct 25.
citation: Quaranta L, Biagioli E, Galli F, Poli D, Rulli E, Riva I, Hollander L, Katsanos A, Longo A, Uva MG, Torri V, Weinreb RN. Latanoprost and Dorzolamide for the Treatment of Pediatric Glaucoma: The Glaucoma Italian Pediatric Study (Gipsy), Design and Baseline Characteristics. Adv Ther. 2016 Aug;33(8):1305-15. doi: 10.1007/s12325-016-0358-x. Epub 2016 Jun 16.
citation: Quaranta L, Biagioli E, Riva I, Galli F, Poli D, Rulli E, Katsanos A, Longo A, Uva MG, Torri V, Weinreb RN. The Glaucoma Italian Pediatric Study (GIPSy): 1-Year Results. J Glaucoma. 2017 Nov;26(11):987-994. doi: 10.1097/IJG.0000000000000773.