Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
Overview
- Phase
- Phase 2
- Intervention
- Latanoprost, Dorzolamide
- Conditions
- Childhood Glaucoma
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Percentage of Eyes With Response
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Luciano Quaranta MD
Associate Professor in Ophthalmology
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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)
Arms & Interventions
Latanoprost, Dorzolamide
According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.
Intervention: Latanoprost, Dorzolamide
Outcomes
Primary Outcomes
Percentage of Eyes With Response
Time Frame: 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 Outcomes
- Time to Treatment Failure (TTF)(3 years)
- Number of Eyes With an Adverse Event (AE)(3 years)