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

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ClinicalTrials.gov Identifier: NCT02214680
Recruitment Status : Unknown
Verified October 2015 by Orna Geyer, Carmel Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2014
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Combigan (Combination of Brimonidine and Timolol) Drug: Timolol Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter
Study Start Date : October 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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
  • Tiloptic
  • Combigan

Drug: Timolol
0.5% eye drop
Other Name: Tiloptic




Primary Outcome Measures :
  1. Pupil diameter [ Time Frame: two weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214680


Contacts
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Contact: Orna Geyer, Professor 97248250926 orna_geyer@clalit.org.il

Locations
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Israel
Carmel Medical Center Not yet recruiting
Haifa, Israel, 34362
Contact: Zina Goldbaum    97248250441    zinago@clalit.org.il   
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Orna Geyer, MD Carmel Medical Center

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Responsible Party: Orna Geyer, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02214680     History of Changes
Other Study ID Numbers: CMC-14-0016-CTIL
CMC-14-0016 ( Other Identifier: Carmel Medical Center )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Orna Geyer, Carmel Medical Center:
Pupil diameter
Brimonidine
Timolol
Combigan
Additional relevant MeSH terms:
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Brimonidine Tartrate
Brimonidine Tartrate, Timolol Maleate Drug Combination
Timolol
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists