The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter

NCT02214680 | Unknown Phase 2

• 2 other identifiers: CMC-14-0016-CTILCMC-14-0016
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.

Conditions

Healthy

Keywords

Pupil diameter; Brimonidine; Timolol; Combigan

Outcome Measures

Primary Outcomes (1)

• Pupil diameter

  two weeks

Study Arms (1)

Combination of Brimonidine and Timolol

EXPERIMENTAL

On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.

Drug: Combigan (Combination of Brimonidine and Timolol); Drug: Timolol

Interventions

Combigan (Combination of Brimonidine and Timolol) DRUG

On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.

Also known as: Alphagan, Tiloptic, Combigan

Combination of Brimonidine and Timolol

Timolol DRUG

0.5% eye drop

Also known as: Tiloptic

Combination of Brimonidine and Timolol

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults subjects with no ocular pathology
• Non pregnant women
• Normal pupil response

You may not qualify if:

• Chronic topical treatment
• Systemic medication affecting autonomic nerve system
• History of intra-ocular surgery
• Irregular pupil
• History of ocular neurological or severe cardio-vascular disease

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

MeSH Terms

Interventions

Brimonidine Tartrate, Timolol Maleate Drug Combination; Timolol; Brimonidine Tartrate

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Morpholines; Oxazines

Study Officials

• Orna Geyer, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orna Geyer, Professor

CONTACT

97248250926; orna_geyer@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 12, 2014
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

IL (1)