Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

NCT01201551 | Completed

• 1 other identifier: 088-Mom-2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Vascular Dysregulation

Keywords

Alphagan; Xalatan; corneal temperature; primary vascular dysregulation

Outcome Measures

Primary Outcomes (1)

• Corneal temperature

  Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.

Secondary Outcomes (3)

• 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.

Study Arms (2)

healthy subjects without PVD

ACTIVE COMPARATOR

healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo

Drug: Brimonidine; Drug: Latanoprost; Drug: Placebo

healthy subjects with PVD

ACTIVE COMPARATOR

healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo

Drug: Brimonidine; Drug: Latanoprost; Drug: Placebo

Interventions

Brimonidine DRUG

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

Also known as: Alphagan

healthy subjects with PVD; healthy subjects without PVD

Latanoprost DRUG

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

Also known as: Xalatan

healthy subjects with PVD; healthy subjects without PVD

Placebo DRUG

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

Also known as: Fermavisc

healthy subjects with PVD; healthy subjects without PVD

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy
• age 18-48 years
• normal findings on ophthalmological examination

You may not qualify if:

• history of ocular or systemic disease
• chronic or current systemic or topical medication
• drug or alcohol abuse
• art. hypertension

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University of Basel, Dept. of Ophthalmology

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Brimonidine Tartrate; Latanoprost

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Josef Flammer, MD

  University of Basel, Dept. of Ophthalmology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: June 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

CH (1)