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

Sponsor

Omeros Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00721695

Collaborator

(none)

Enrollment

Locations

Arms

9.1

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cataract Extraction	Drug: OMS302 Drug: OMS302-PE Drug: Vehicle	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 OMS302 Irrigation Solution	Drug: OMS302 OMS302 Irrigation Solution Other Names: OMS302 Irrigation Solution
Active Comparator: 2 OMS302-PE HCl Irrigation Solution	Drug: OMS302-PE OMS302-PE HCI Irrigation Solution Other Names: OMS302-PE HCI Irrigation Solution
Placebo Comparator: 3 Standard topical mydriatics and BSS Irrigation Solution	Drug: Vehicle Standard topical mydriatics and Balanced Salt Solution Irrigation Solution Other Names: Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

Arm

Intervention/Treatment

Experimental: 1

OMS302 Irrigation Solution

Drug: OMS302

OMS302 Irrigation Solution

Other Names:

OMS302 Irrigation Solution

Active Comparator: 2

OMS302-PE HCl Irrigation Solution

Drug: OMS302-PE

OMS302-PE HCI Irrigation Solution

Other Names:

OMS302-PE HCI Irrigation Solution

Placebo Comparator: 3

Standard topical mydriatics and BSS Irrigation Solution

Drug: Vehicle

Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

Other Names:

Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

Outcome Measures

Primary Outcome Measures

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

Ocular safety and changes in visual activity and intraocular pressure [28 days]
General measures of safety [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Shasta Eye Medical Group	Redding	California	United States	96002
2	Chu Vision Institute	Bloomington	Minnesota	United States	55420
3	Silverstein Eye Centers	Kansas City	Missouri	United States	64133
4	Davis Duehr Dean	Madison	Wisconsin	United States	53715