Treatment of Pediatric Glaucoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Azienda Ospedaliera Spedali Civili di Brescia
Sponsor:
Information provided by (Responsible Party):
Luciano Quaranta, MD, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT01527682
First received: February 16, 2010
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Childhood Glaucoma
Drug: Latanoprost, Dorzolamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topically Applied Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Spedali Civili di Brescia:

Primary Outcome Measures:
  • percentage of "responder" [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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

  • Incidence of adverse events (AEs) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 68
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Latanoprost, Dorzolamide
According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.
Drug: Latanoprost, Dorzolamide
  • 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
Other Names:
  • - Latanoprost, a prostaglandin analogue
  • - Dorzolamide, a potent inhibitor of carbonic anhydrase II

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

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 uveae, 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, ACE-inhibitors diuretics, etc.)
  • Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527682

Contacts
Contact: Luciano Quaranta 0303995847 ext +39 luciano_quaranta@mac.com

Locations
Italy
Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico Recruiting
Catania, Italy, 95123
Contact: Maurizio Uva, MD    +390953781050    mauruva56@virgilio.it   
Contact: Antonio Longo, MD    +390953781050    ant-longo@libero.it   
Policlinico di Monza Active, not recruiting
Monza, Italy, 20052
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
Principal Investigator: Luciano Quaranta, MD Università di Brescia, Spedali Civili di Brescia
  More Information

No publications provided

Responsible Party: Luciano Quaranta, MD, Associate Professor in Ophthalmology, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT01527682     History of Changes
Other Study ID Numbers: 2008-004763-19
Study First Received: February 16, 2010
Last Updated: July 18, 2013
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera Spedali Civili di Brescia:
Intraocular pressure
Latanoprost
Dorzolamide

Additional relevant MeSH terms:
Glaucoma
Hydrophthalmos
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases
Carbonic Anhydrase Inhibitors
Dorzolamide
Latanoprost
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014