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Completed

NCT Number: NCT01201551

Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

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.

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Key information

Conditions

Primary Vascular Dysregulation

Age range

18 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel, Dept. of Ophthalmology

Basel, 4031, Switzerland

About this study

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:

  • Do the individual drugs influence the circulation to the eye as quantified indirectly via corneal temperature?
  • Does the combination of Alphagan and Xalatan give an additive or even potentiated effect?
  • Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan second, or vice versa)?
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brimonidine

Drug

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

Other names: Alphagan

latanoprost

Drug

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

Other names: Xalatan

Placebo

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

Other names: Fermavisc

Primary outcomes

  1. Corneal temperature

    Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

Secondary outcomes

  1. Intraocular pressure

    Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

  2. Ear temperature

    Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

  3. Blood pressure

    Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 14, 2010
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.