- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01527682
Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brescia, Italy, 25123
- Azienda Ospedaliera Spedali Civili di Brescia
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Catania, Italy, 95123
- A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Latanoprost, Dorzolamide
According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Eyes With Response
Time Frame: 3 years
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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
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Treatment Failure (TTF)
Time Frame: 3 years
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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
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3 years
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Number of Eyes With an Adverse Event (AE)
Time Frame: 3 years
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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.
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3 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Luciano Quaranta, MD, Università di Brescia, Spedali Civili di Brescia
Publications and helpful links
General Publications
- 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.
- 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.
- 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 Glaucoma. 2018 May;27(5):e105.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-004763-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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