Treatment of Pediatric Glaucoma
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.
|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|
- 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
- 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.
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.
Drug: Latanoprost, Dorzolamide
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.
|Contact: Luciano Quaranta||0303995847 ext +email@example.com|
|Azienda Ospedaliera Spedali Civili di Brescia||Recruiting|
|Brescia, Italy, 25123|
|Policlinico di Monza||Active, not recruiting|
|Monza, Italy, 20052|
|Principal Investigator:||Luciano LQ Quaranta, Medical Doctors||Università di Brescia, Spedali Civili di Brescia|