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Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01201551
First received: September 13, 2010
Last updated: December 10, 2013
Last verified: December 2013

September 13, 2010
December 10, 2013
June 2011
November 2013   (final data collection date for primary outcome measure)
Corneal temperature [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01201551 on ClinicalTrials.gov Archive Site
  • Intraocular pressure [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ] [ Designated as safety issue: No ]
  • Ear temperature [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature
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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Primary Vascular Dysregulation
  • 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 without PVD
    healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
    Interventions:
    • Drug: Brimonidine
    • Drug: Latanoprost
    • Drug: Placebo
  • Active Comparator: healthy subjects with PVD
    healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
    Interventions:
    • Drug: Brimonidine
    • Drug: Latanoprost
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 48 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01201551
088-Mom-2010
No
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Study Director: Josef Flammer, MD University of Basel, Dept. of Ophthalmology
University Hospital, Basel, Switzerland
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP