Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification. - Full Text View

Sponsored by:	Omeros Corporation
Information provided by:	Omeros Corporation
ClinicalTrials.gov Identifier:	NCT00721695

Purpose

This is an exploratory study to determine the safety and clinical benefit of OMS302 Injection in subjects undergoing Cataract Extraction with Lens Replacement (CELR) using a coaxial phacoemulsification process.

Condition	Intervention	Phase
Cataract Extraction	Drug: OMS302 Drug: OMS302-PE Drug: Vehicle	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Controlled, Double-Masked, Multicenter, Exploratory Study of the Clinical Benefit and Safety of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR) Using a Coaxial Phacoemulsification Process

Resource links provided by NLM:

MedlinePlus related topics: Cataract

U.S. FDA Resources

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:

Pupil diameter [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
Pain and other measures of ocular discomfort [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Degree of inflammation in the anterior chamber [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ocular safety and changes in visual activity and intraocular pressure [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
General measures of safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental OMS302 Irrigation Solution	Drug: OMS302 OMS302 Irrigation Solution
2: Active Comparator OMS302-PE HCl Irrigation Solution	Drug: OMS302-PE OMS302-PE HCI Irrigation Solution
3: Placebo Comparator Standard topical mydriatics and BSS Irrigation Solution	Drug: Vehicle Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

Detailed Description:

OMS302 Injection is a mydriatic/anti-inflammatory combination investigational drug product being developed as an irrigation solution during intracameral lens replacement surgical procedures of the eye. OMS302 irrigation solution may induce and maintain an adequately dilated pupil and reduce postoperative symptoms of discomfort such as eye pain and irritation. The use of OMS302 irrigation solution may eliminate the need for pre-operative dilation of the eye and could reduce the postoperative use of an anti-inflammatory and pain medications following surgery.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is 50 years of age or older.
Subject is to undergo unilateral primary CELR for an age-related cataract under topical anesthesia and using a clear cornea incision.
Subject's history and physical examination are within normal limits or the examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.
Subject has best corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.
Subject has intraocular pressure (IOP) between 5 mmHg and 22 mmHg, inclusive, in the study eye.

Exclusion Criteria:

Subject is allergic to any of the individual ingredients in OMS302
Subject who is taking medications with the same activities as that of the active ingredients in OMS302 for defined time intervals prior to and after surgery.
Female subject of childbearing potential (i.e., not surgically sterilized nor post-menopausal longer than one year) who is not using an effective method of birth control within at least 14 days prior to surgery or has a positive pregnancy test.
Subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory, or medical disorder as determined by the Investigator.
Subject who is taking anticoagulants.
Subject who is taking or needs to take for the duration of the study any of the prohibited medications.
Subject with pseudo-capsular exfoliation, or evidence of prior iritis or of ocular trauma with iris damage, or who has used pilocarpine within six months of screening.
Subject that has uncontrolled chronic ocular disease.
Subject that has active corneal pathology or scarring noted in either eye (except superficial punctate keratopathy in the non-study eye).
Subject that has extraocular/intraocular inflammation in either eye.
Subject has an active bacterial and/or viral infection in either eye.
Subject that has narrow-angle glaucoma, unstable glaucoma, or glaucoma being treated with prostaglandins or prostaglandin analogues.
Subject taking, or has taken within the past year, an alpha adrenergic antagonist.
Subject that has participated in or is currently participating in any investigational drug or device trial within the previous 30 days prior to the day of surgery.
Subject that has had intraocular conventional surgery within the past three months or intraocular laser surgery within one month of the planned surgery in the study eye.
Subject that requires the use of other topical medications during the trial except prophylactic antibiotics, topical lid care or glaucoma medications or tear replacement solutions.
Subject that needs other ocular surgery at the time of the cataract extraction.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721695

Locations

United States, California
Shasta Eye Medical Group
Redding, California, United States, 96002
United States, Minnesota
Chu Vision Institute
Bloomington, Minnesota, United States, 55420
United States, Missouri
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
United States, Wisconsin
Davis Duehr Dean
Madison, Wisconsin, United States, 53715

Sponsors and Collaborators

Omeros Corporation

Investigators

Study Director:

Paul Strauss, MD

Omeros Corporation

More Information

Publications:

Behndig A, Eriksson A. Evaluation of surgical performance with intracameral mydriatics in phacoemulsification surgery. Acta Ophthalmol Scand. 2004 Apr;82(2):144-7.

Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. J Cataract Refract Surg. 2003 Dec;29(12):2366-71.

Responsible Party:	Omeros Corporation ( Gregory Demopulos, MD, CEO, CMO )
Study ID Numbers:	C07-005
Study First Received:	July 22, 2008
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00721695 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Omeros Corporation:

Cataract
Cataract Extraction
Lens Implantation
Phacoemulsification

Study placed in the following topic categories:

Mydriatics
Eye Diseases
Cataract
Lens Diseases
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Mydriatics
Autonomic Agents
Eye Diseases
Cataract

Physiological Effects of Drugs
Lens Diseases
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009