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

February 16, 2010
July 18, 2013
July 2009
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01527682 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 (hypertricosis), changes iris colour, corneal epitheliopathy, allergic conjunctivitis, increase of central corneal thickness, non-serious and serious adverse event occurrence.
Not Provided
Not Provided
 
Treatment of Pediatric Glaucoma
Efficacy and Safety of Topically Applied 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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Childhood Glaucoma
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
Latanoprost, Dorzolamide
According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.
Intervention: Drug: Latanoprost, Dorzolamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
December 2013
October 2013   (final data collection date for primary outcome measure)

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)
Both
up to 12 Years
No
Contact: Luciano Quaranta 0303995847 ext +39 luciano_quaranta@mac.com
Italy
 
NCT01527682
2008-004763-19
Yes
Luciano Quaranta, MD, Azienda Ospedaliera Spedali Civili di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
Not Provided
Principal Investigator: Luciano Quaranta, MD Università di Brescia, Spedali Civili di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP