Text Size

Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

This study is currently recruiting participants.
Verified August 2012 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01201551
First received: September 13, 2010
Last updated: August 24, 2012
Last verified: August 2012
History of Changes
  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 Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Resource links provided by NLM:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

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. ] [ 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 ]

Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • age 20-50 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201551

Contacts
Contact: Katarzyna Konieczka, MD +41 61 265 8803 kkonieczka@uhbs.ch
Contact: Maneli Mozaffarieh, MD +41 61 265 8807 mmozaffarieh@uhbs.ch

Locations
Switzerland
University of Basel, Dept. of Ophthalmology Recruiting
Basel, Switzerland, 4031
Contact: Maneli Mozaffarieh, MD     +41 61 265 8807     mmozaffarieh@uhbs.ch    
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Josef Flammer, MD University of Basel, Dept. of Ophthalmology
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01201551     History of Changes
Other Study ID Numbers: 088-Mom-2010
Study First Received: September 13, 2010
Last Updated: August 24, 2012
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Tetrahydrozoline
Brimonidine
Latanoprost
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 22, 2013