search
Back to results

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

Primary Purpose

Childhood Glaucoma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Latanoprost, Dorzolamide
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Glaucoma focused on measuring Intraocular pressure, Latanoprost, Dorzolamide

Eligibility Criteria

1 Month - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Azienda Ospedaliera Spedali Civili di Brescia
  • A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Latanoprost, Dorzolamide

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
February 16, 2010
Last Updated
September 11, 2019
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
search

1. Study Identification

Unique Protocol Identification Number
NCT01527682
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Glaucoma
Keywords
Intraocular pressure, Latanoprost, Dorzolamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latanoprost, Dorzolamide
Arm Type
Other
Arm Description
According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.
Intervention Type
Drug
Intervention Name(s)
Latanoprost, Dorzolamide
Other Intervention Name(s)
- Latanoprost, a prostaglandin analogue, - Dorzolamide, a potent inhibitor of carbonic anhydrase II
Intervention Description
Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM) Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost
Primary Outcome Measure Information:
Title
Percentage of Eyes With Response
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Time to Treatment Failure (TTF)
Description
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
Time Frame
3 years
Title
Number of Eyes With an Adverse Event (AE)
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano Quaranta, MD
Organizational Affiliation
Università di Brescia, Spedali Civili di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
City
Catania
ZIP/Postal Code
95123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24158022
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.
Results Reference
background
PubMed Identifier
27312975
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.
Results Reference
result
PubMed Identifier
28957960
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 Glaucoma. 2018 May;27(5):e105.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs