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.

Study Overview

• Status: Completed
• Conditions: Primary Vascular Dysregulation
• Intervention / Treatment: Drug: Brimonidine; Drug: Latanoprost; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University of Basel, Dept. of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Intraocular pressure	Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Ear temperature	Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Blood pressure	Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Director: Josef Flammer, MD, University of Basel, Dept. of Ophthalmology

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Xalatan; Alphagan; corneal temperature; primary vascular dysregulation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Pharmaceutical Solutions; Ophthalmic Solutions; Brimonidine Tartrate; Latanoprost
• Other Study ID Numbers: 088-Mom-2010