NCT01527682

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

Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 1 Month – 12 Years
• Healthy volunteers: Not accepted

Summary

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. This number of eyes could be achieved by recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for the study.

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.

Conditions

• Childhood Glaucoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-07-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2012-02-07
• Last updated: 2019-09-27
• Results posted: 2019-09-27

Locations

2 sites across 1 country: Italy