This trial is active, not recruiting.

Condition childhood glaucoma
Treatment latanoprost, dorzolamide
Phase phase 2
Sponsor Azienda Ospedaliera Spedali Civili di Brescia
Start date July 2009
End date January 2017
Trial size 69 participants
Trial identifier NCT01527682, 2008-004763-19



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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.
latanoprost, dorzolamide - Latanoprost, a prostaglandin analogue
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

Primary Outcomes

percentage of "responder"
time frame: 3 years

Secondary Outcomes

Time to treatment failure (TTF)
time frame: 3 years
Incidence of adverse events (AEs)
time frame: 3 years

Eligibility Criteria

Male or female participants up to 12 years old.

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)

Additional Information

Official title Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
Principal investigator Luciano Quaranta, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Azienda Ospedaliera Spedali Civili di Brescia.