Childhood Glaucoma Clinical Trial
Official title:
Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
| Verified date | September 2019 |
| Source | Azienda Ospedaliera Spedali Civili di Brescia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Month to 12 Years |
| 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) |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Ospedaliera Spedali Civili di Brescia | Brescia | |
| Italy | A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico | Catania |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Ospedaliera Spedali Civili di Brescia |
Italy,
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 — View 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. Erratum in: J — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Eyes With Response | 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 | 3 years | |
| Secondary | Time to Treatment Failure (TTF) | 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 | 3 years | |
| Secondary | Number of Eyes With an Adverse Event (AE) | 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. | 3 years |