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Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT01201551
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
29
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
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
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Alphagan

    • Drug: Latanoprost
    Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
    Other Names:
  • 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 Names:
  • 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 Names:
  • Alphagan

    • Drug: Latanoprost
    Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
    Other Names:
  • 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 Names:
  • Fermavisc

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Corneal temperature [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]

    Secondary Outcome Measures

    1. Intraocular pressure [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]

    2. Ear temperature [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]

    3. Blood pressure [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 48 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT01201551
    Other Study ID Numbers:
    • 088-Mom-2010
    First Posted:
    Sep 14, 2010
    Last Update Posted:
    Dec 11, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by University Hospital, Basel, Switzerland
    Alphagan
    Xalatan
    corneal temperature
    primary vascular dysregulation
    Additional relevant MeSH terms:
    Brimonidine Tartrate
    Latanoprost

    Study Results

    No Results Posted as of Dec 11, 2013