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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Luciano Quaranta MD, Azienda Ospedaliera Spedali Civili di Brescia Identifier:
First received: February 16, 2010
Last updated: August 31, 2015
Last verified: August 2015


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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of 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 ]
    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 ]
    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 ]
    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.

Enrollment: 69
Study Start Date: July 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: January 2017 (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.


Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, ACE-inhibitors diuretics, etc.)
  • Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01527682

Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
Catania, Italy, 95123
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Principal Investigator: Luciano Quaranta, MD Università di Brescia, Spedali Civili di Brescia
  More Information

Responsible Party: Luciano Quaranta MD, Associate Professor in Ophthalmology, Azienda Ospedaliera Spedali Civili di Brescia Identifier: NCT01527682     History of Changes
Other Study ID Numbers: 2008-004763-19
Study First Received: February 16, 2010
Last Updated: August 31, 2015

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Carbonic Anhydrase Inhibitors
Antihypertensive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017