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

October 13, 2015 updated by: Orna Geyer, Carmel Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

The study subjects will be examined twice, two weeks apart. On the first exam the subject will receive Combigan 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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 34362
        • Carmel Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Combination of Brimonidine and Timolol
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)
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.
Other Names:
  • Alphagan
  • Combigan
  • Tiloptic
Drug: Timolol
0.5% eye drop
Other Names:
  • Tiloptic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pupil diameter
Time Frame: two weeks
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (ESTIMATE)

August 12, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-14-0016-CTIL
  • CMC-14-0016 (OTHER: Carmel Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Combigan (Combination of Brimonidine and Timolol)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe