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Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01201551
Enrollment
40
Registered
2010-09-14
Start date
2011-06-30
Completion date
2013-11-30
Last updated
2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Vascular Dysregulation

Keywords

Alphagan, Xalatan, corneal temperature, primary vascular dysregulation

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.

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).

Interventions

Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye

DRUGLatanoprost

Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye

DRUGPlacebo

Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 48 Years
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

Design outcomes

Primary

MeasureTime frame
Corneal temperatureWeek 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

Secondary

MeasureTime frame
Intraocular pressureWeek 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Ear temperatureWeek 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Blood pressureWeek 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026