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

I

Israel Healthcare Foundation

Status and phase

Unknown
Phase 2

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02214680
CMC-14-0016 (Other Identifier)
CMC-14-0016-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Combination of Brimonidine and Timolol
Experimental group
Description:
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.
Treatment:
Drug: Combigan (Combination of Brimonidine and Timolol)
Drug: Timolol

Trial contacts and locations

1

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Central trial contact

Orna Geyer, Professor

Data sourced from clinicaltrials.gov

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