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

NCT ID: NCT02214680

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Combigan (Combination of Brimonidine and Timolol)

Intervention Type 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.

Timolol

Intervention Type DRUG

0.5% eye drop

Interventions

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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.

Intervention Type DRUG

Timolol

0.5% eye drop

Intervention Type DRUG

Other Intervention Names

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Alphagan Tiloptic Combigan Tiloptic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Orna Geyer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orna Geyer, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

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Carmel Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Orna Geyer, Professor

Role: CONTACT

97248250926

Facility Contacts

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Zina Goldbaum

Role: primary

97248250441

Other Identifiers

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CMC-14-0016

Identifier Type: OTHER

Identifier Source: secondary_id

CMC-14-0016-CTIL

Identifier Type: -

Identifier Source: org_study_id

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