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Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

NCT ID: NCT01201551

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-11-30

Brief Summary

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It is already known that the local treatment with Alphagan eye drops (a drug commonly used by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD). To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take measurements of corneal temperature as surrogate for ocular blood flow.

Detailed Description

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The investigators would like to investigate the effect of Alphagan eye drops, Xalatan eye drops and their combination (both Alphagan and Xalatan) on corneal temperature in healthy subjects with and without a primary vascular dysregulation (PVD).

The investigators would like to answer the following questions:

1. Do the individual drugs influence the circulation to the eye as quantified indirectly via corneal temperature?
2. Does the combination of Alphagan and Xalatan give an additive or even potentiated effect?
3. Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan second, or vice versa)?
4. Do PVD and non-PVD subjects respond differently to these drugs?

20 healthy non-PVD subjects and 20 healthy PVD subjects in the age range from 20-40 years will be recruited. Recruited subjects will have all measurements: corneal temperature, intraocular pressure (IOP), ear temperature, blood-pressure. Both prior to and after instillation of eye drops (Xalatan, Alphagan and placebo).

Conditions

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Primary Vascular Dysregulation

Keywords

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Alphagan Xalatan corneal temperature primary vascular dysregulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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healthy subjects without PVD

healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo

Group Type ACTIVE_COMPARATOR

Brimonidine

Intervention Type DRUG

Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye

Latanoprost

Intervention Type DRUG

Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye

Placebo

Intervention Type DRUG

Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye

healthy subjects with PVD

healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo

Group Type ACTIVE_COMPARATOR

Brimonidine

Intervention Type DRUG

Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye

Latanoprost

Intervention Type DRUG

Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye

Placebo

Intervention Type DRUG

Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye

Interventions

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Brimonidine

Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye

Intervention Type DRUG

Latanoprost

Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye

Intervention Type DRUG

Placebo

Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye

Intervention Type DRUG

Other Intervention Names

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Alphagan Xalatan Fermavisc

Eligibility Criteria

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Inclusion Criteria

* healthy
* age 18-48 years
* normal findings on ophthalmological examination

Exclusion Criteria

* history of ocular or systemic disease
* chronic or current systemic or topical medication
* drug or alcohol abuse
* art. hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josef Flammer, MD

Role: STUDY_DIRECTOR

University of Basel, Dept. of Ophthalmology

Locations

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University of Basel, Dept. of Ophthalmology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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088-Mom-2010

Identifier Type: -

Identifier Source: org_study_id