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Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201551
First Posted: September 14, 2010
Last Update Posted: December 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
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.

Condition Intervention
Primary Vascular Dysregulation Drug: Brimonidine Drug: Latanoprost Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Intraocular pressure [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ]
  • Ear temperature [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ]
  • Blood pressure [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ]

Enrollment: 40
Study Start Date: June 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: healthy subjects without PVD
healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
Drug: Brimonidine
Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye
Other Name: Alphagan
Drug: Latanoprost
Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
Other Name: Xalatan
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
Other Name: Fermavisc
Active Comparator: healthy subjects with PVD
healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
Drug: Brimonidine
Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye
Other Name: Alphagan
Drug: Latanoprost
Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
Other Name: Xalatan
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
Other Name: Fermavisc

Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201551


Locations
Switzerland
University of Basel, Dept. of Ophthalmology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Josef Flammer, MD University of Basel, Dept. of Ophthalmology
  More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01201551     History of Changes
Other Study ID Numbers: 088-Mom-2010
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by University Hospital, Basel, Switzerland:
Alphagan
Xalatan
corneal temperature
primary vascular dysregulation

Additional relevant MeSH terms:
Ophthalmic Solutions
Latanoprost
Brimonidine Tartrate
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs