drugset / Trial / NCT01655758

24-hour Control of Intraocular Pressure (IOP) in Ocular Hypertension

NCT01655758

Phase 4 Completed 61 enrolled University of Parma
RandomizedCrossoverDouble-blindTreatment

Summary

This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. The enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that outflow drugs may offer a better and more stable control of IOP through the 24 hours.

Timeline

Start
2002-01
Primary completion
2003-12
Completion
2004-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bimatoprost Other / unclassified 0.03 % Topical
Comparator Dorzolamide Small molecule 2 % Topical
Comparator Latanoprost Small molecule 0.005 % Topical
Comparator Timolol Other / unclassified 0.5 % Topical
Comparator Travoprost Other / unclassified 0.004 % Topical

Indications