NCT00308945

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

Enrollment Period

1.3 years

First QC Date

March 29, 2006

Last Update Submit

January 14, 2008

Conditions

Open-Angle Glaucoma

Keywords

GlaucomaBlood flowChoroidRetinaProstaglandin analogues

Outcome Measures

Primary Outcomes (1)

  • effect on choroidal blood flow

    baseline - 2 weeks - 4 weeks

Secondary Outcomes (1)

  • effect on retinal vascular diameter

    baseline - 2 weeks - 4 weeks

Study Arms (2)

2

EXPERIMENTAL

cross-over comparison of two substances

Drug: latanoprost 0.005% (drug)

1

EXPERIMENTAL
Drug: travoprost 0.004% (drug)

Interventions

travoprost 0.004% (drug)DRUG

local drop application

1
latanoprost 0.005% (drug)DRUG

local drop application

2

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Links

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

TravoprostPharmaceutical PreparationsLatanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Selim Orgul, MD

    University Eye Clinic Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 30, 2006

Study Start

November 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

CH(1)