Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Primary Vascular Dysregulation Clinical Trial

Official title:

Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201551
• Other study ID #: 088-Mom-2010
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: December 10, 2013
• Start date: June 2011
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 48 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Vascular Dysregulation

Intervention

Drug:
• Brimonidine
Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye
• Latanoprost
Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
• 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

Locations

Country	Name	City	State
Switzerland	University of Basel, Dept. of Ophthalmology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal temperature		Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.	No
Secondary	Intraocular pressure		Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.	No
Secondary	Ear temperature		Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.	No
Secondary	Blood pressure		Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.	No