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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Parma
• Treatments: Bimatoprost; Dorzolamide; Latanoprost; Timolol; Travoprost

Criteria

Inclusion Criteria:

• IOP > 22 mmHg and < 30 mmHg on at least three readings on separate days ,

• Open angle on gonioscopy,

• CCT > 550 m,

• optic disk classified as "within normal limits" by Moorfields Regression analysis, HRTII,

• normal visual field (standard achromatic perimetry, Humphrey Field Analyzer, 24/2 SITA standard),

• Age > 40 and < 70 years,

• refraction between - 5 and + 2 dyopters,

• best corrected visual acuity better than 0.2 LogMAR,

Exclusion Criteria:

• PEX

• PDS

• ocular comorbidiities other than refractive problems and/or mild dry eye

• history of diabetes

• treatment with systemic beta blockers and steroids

• previous treatment with ocular hypotensive drugs