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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02214680
• Other study ID #: CMC-14-0016-CTIL
• Secondary ID: CMC-14-0016
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 11, 2014
• Last updated: October 13, 2015
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Carmel Medical Center
• Contact: Orna Geyer, Professor
• Phone: 97248250926
• Email: orna_geyer[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• Timolol
0.5% eye drop

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil diameter		two weeks	No