Overview
Influence of Prostaglandins on Ocular Blood Flow in Glaucoma Patients
Status:
Completed
Completed
Trial end date:
2005-02-01
2005-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The purpose of this study is to compare the effect of travoprost 0.004% and latanoprost 0.005% on choroidal blood flow and retinal vascular diameter in glaucoma patients. After washout of current topical medication, intraocular pressure (IOP) in both eyes (Goldmann applanation tonometry), choroidal blood flow (laser Doppler flowmetry) and retinal vessel diameter (Retinal Vessel Analyzer) in one randomly selected eye will be measured at baseline, after two weeks and after 4 weeks of treatment with travoprost or latanoprost QD, in a randomized, double masked 2-way cross-over study in 20 open angle glaucoma patients.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital, Basel, SwitzerlandTreatments:
Latanoprost
Travoprost
Criteria
Inclusion Criteria:- Patients fulfilling two out of three of the following criteria in one or both eyes: a)
typical glaucomatous disc, b) visual field damage (a cluster of three points (except
rim points) in at least one hemifield reduced by 5 dB or greater and including at
least one point reduced by 10 dB or greater; a cluster of two points reduced by 10 dB
or greater; or three adjacent points on the nasal horizontal meridian that differed by
5 dB or greater from their mirror points on the opposite side of the meridian), c)
intraocular pressure above 21 mm Hg at least at one occasion after washout. No closed
iridocorneal angles, evidence of secondary glaucoma, pseudoexfoliation, pigmentary
dispersion, or any form of retinal or neuroophthalmologic disease that could result in
visual field defects. No history of drug or alcohol abuse.
Exclusion Criteria:
- Best corrected visual acuity worse than 2/10 in either eye < 0.2 Snellen. Inadequate
transparency of ocular media as defined by physical examination. Severe central field
loss defined as a sensitivity < 10dB in at least 2 of the 4 visual field test points
closest to the point of fixation. Any abnormality which in the physician's view would
prevent reliable applanation tonometry or LDF of both eyes, including an ametropia >3
dpt. History of chronic or recurrent severe inflammatory eye disease such as scleritis
or uveitis. History of ocular trauma or intraocular surgery within the past 6 months.
History of infection or inflammation within the past 3 months. History of clinically
significant or progressive retinal disease such as retinal degeneration, diabetic
retinopathy or retinal detachment. A known hypersensitivity to the compounds tested.
Need for any concomitant medications that may interfere with the evaluation of ocular
blood flow. Variability > 30 % during Laser Doppler Flowmetry (sample of 6
measurements) in both eyes. Pregnancy, breastfeeding, or women in childbearing age
without adequate contraception.