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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527682
Recruitment Status : Unknown
Verified August 2015 by Luciano Quaranta MD, Azienda Ospedaliera Spedali Civili di Brescia.
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2012
Last Update Posted : September 1, 2015
Information provided by (Responsible Party):
Luciano Quaranta MD, Azienda Ospedaliera Spedali Civili di Brescia

Brief Summary:


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 or disease Intervention/treatment Phase
Childhood Glaucoma Drug: Latanoprost, Dorzolamide Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
Study Start Date : July 2009
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Luciano Quaranta MD, Azienda Ospedaliera Spedali Civili di Brescia:
Intraocular pressure

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases
Carbonic Anhydrase Inhibitors
Antihypertensive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action