- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721695
Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.
July 16, 2014 updated by: Omeros Corporation
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Redding, California, United States, 96002
- Shasta Eye Medical Group
-
-
Minnesota
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Bloomington, Minnesota, United States, 55420
- Chu Vision Institute
-
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Missouri
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Kansas City, Missouri, United States, 64133
- Silverstein Eye Centers
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Wisconsin
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Madison, Wisconsin, United States, 53715
- Davis Duehr Dean
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
OMS302 Irrigation Solution
|
OMS302 Irrigation Solution
Other Names:
|
Active Comparator: 2
OMS302-PE HCl Irrigation Solution
|
OMS302-PE HCI Irrigation Solution
Other Names:
|
Placebo Comparator: 3
Standard topical mydriatics and BSS Irrigation Solution
|
Standard topical mydriatics and Balanced Salt Solution Irrigation Solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pupil diameter
Time Frame: Day of Surgery
|
Day of Surgery
|
Pain and other measures of ocular discomfort
Time Frame: 14 days
|
14 days
|
Degree of inflammation in the anterior chamber
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ocular safety and changes in visual activity and intraocular pressure
Time Frame: 28 days
|
28 days
|
General measures of safety
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Scott Houston, Omeros Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Behndig A, Eriksson A. Evaluation of surgical performance with intracameral mydriatics in phacoemulsification surgery. Acta Ophthalmol Scand. 2004 Apr;82(2):144-7. doi: 10.1111/j.1600-0420.2004.00241.x.
- Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. J Cataract Refract Surg. 2003 Dec;29(12):2366-71. doi: 10.1016/s0886-3350(03)00522-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
July 22, 2008
First Submitted That Met QC Criteria
July 22, 2008
First Posted (Estimate)
July 24, 2008
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 16, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C07-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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