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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT01527682
Study type Interventional
Source Azienda Ospedaliera Spedali Civili di Brescia
Contact
Status Completed
Phase Phase 2
Start date July 2009
Completion date November 2016