Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery

Most patients undergoing cataract surgery suffer from corneal edema after the surgery.

Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they had normal intra-ocular pressure.

The investigators believe that administering topical Brimonidine to patients with significant post operative corneal edema will hasten the resolution of their corneal edema.

Study Overview

• Status: Unknown
• Conditions: Corneal Edema; Visual Acuity
• Intervention / Treatment: Drug: Brimonidine Tartrate 0.2%; Drug: Timolol maleate 0.5%

Detailed Description

Most patients undergoing cataract surgery suffer from corneal edema after the surgery which temporarily reduces their visual acuity until corneal edema resolves over several weeks Brimonidine drops are a well known and safe Anti-glaucoma medication, used to lower intra ocular pressure.

there have been several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even in the presence of normal intra-ocular pressure.

The investigators postulated that administering topical Brimonidine to patients with significant post operative corneal edema will hasten their recovery and visual improvement.

In order to prove that Brimonidine drops contribute to faster resolution of cornel edema and visual improvement, the study will randomly compare 50 post cataract surgery patients (group A)who will be administered Brimonidine to 2 control groups (50 people in each group):

group B will be given topical timolol drops 0.5% (another well recognized anti glaucoma medication which reduces intra-ocular pressure by different mechanism than Brimonidine.

Group C will not be given any test drug. All 3 groups will receive the regular post operative medications which include corticosteroids and antibiotics.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anat Robinson, MD; Phone Number: 9729377176; Email: robina@clalit.org.il
• Study Contact Backup: Name: Omer Y Bialer, MD; Phone Number: 9729377171; Email: omerb@clalit.org.il

Study Locations

• Israel
  • Petah-Tikva, Israel, 49100
    • Rabin medical center ophthalmology deparment
    • Contact: Weinberger Dov, MD; Phone Number: 9729376101; Email: dwin@clalit.org.il
    • Contact: Omer bialer, MD; Phone Number: 9729377171; Email: omerb@clalit.org.il
    • Sub-Investigator: omer y bialer, MD
    • Principal Investigator: Anat Robinson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1 day after uneventful cataract surgery
• corneal edema (grade 2 to 3)

Exclusion Criteria:

• glaucoma
• higher than normal intraocular pressure (>23 mm Hg)
• known sensitivity or contra indication to brimonidine
• known sensitivity or contra indication to timolol
• pre operative corneal or anterior segment disease
• intraoperative complications
• major ocular pathology other than corneal that reduced vision (retinal degeneration, optic neuropathy etc.)
• pregnant women
• children

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: brimonidine; 50 patients receiving Brimonidine Tartrate drops in the operated eye: 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops)	Drug: Brimonidine Tartrate 0.2%; Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye; Other Names: ALPHAGAN P
Active Comparator: 2 tmolol; 50 patients receiving timolol maleate 0.5% drops in the operated eye 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops)	Drug: Timolol maleate 0.5%; timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye; Other Names: TILOPTIC; V-OPTIC
No Intervention: 3; 50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
central corneal thickness in micrometer	day 0 (day of enrollment ), day 7, day 30

Secondary Outcome Measures

Outcome Measure	Time Frame
grading of corneal edema (1-3)	day 0 (day of enrollment), day 7, day 30

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Anat Robinson, MD, Rabin medical center, Clalit health services , Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): January 1, 2010
• Study Completion (Anticipated): January 1, 2010

Study Registration Dates

• First Submitted: November 30, 2008
• First Submitted That Met QC Criteria: December 1, 2008
• First Posted (Estimate): December 2, 2008

Study Record Updates

• Last Update Posted (Estimate): December 2, 2008
• Last Update Submitted That Met QC Criteria: December 1, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: cataract surgery; postoperative; timolol; visual acuity; brimonidine; corneal edema; postoperative corneal edema; central corneal thickness
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Corneal Diseases; Cataract; Edema; Corneal Edema; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Timolol; Brimonidine Tartrate
• Other Study ID Numbers: 5189