Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cataract Extraction

Intervention / Treatment
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* Drug: OMS302
* Drug: OMS302-PE
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>OMS302 Irrigation Solution | Drug: OMS302<br>* OMS302 Irrigation Solution<br>* Other names: OMS302 Irrigation Solution;|
| Active Comparator: 2<br>OMS302-PE HCl Irrigation Solution | Drug: OMS302-PE<br>* OMS302-PE HCI Irrigation Solution<br>* Other names: OMS302-PE HCI Irrigation Solution;|
| Placebo Comparator: 3<br>Standard topical mydriatics and BSS Irrigation Solution | Drug: Vehicle<br>* Standard topical mydriatics and Balanced Salt Solution Irrigation Solution<br>* Other names: Standard topical mydriatics and Balanced Salt Solution Irrigation Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil diameter |  | Day of Surgery | 
| Pain and other measures of ocular discomfort |  | 14 days | 
| Degree of inflammation in the anterior chamber |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety and changes in visual activity and intraocular pressure |  | 28 days | 
| General measures of safety |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Cataract Extraction, Lens Implantation, Phacoemulsification