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

NCT00721695 | Completed Phase 1

• 1 other identifier: C07-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Cataract Extraction

Keywords

Cataract; Cataract Extraction; Lens Implantation; Phacoemulsification

Outcome Measures

Primary Outcomes (3)

• Pupil diameter

  Day of Surgery

• Pain and other measures of ocular discomfort

  14 days

• Degree of inflammation in the anterior chamber

  14 days

Secondary Outcomes (2)

• Ocular safety and changes in visual activity and intraocular pressure

  28 days

• General measures of safety

  28 days

Study Arms (3)

1

EXPERIMENTAL

OMS302 Irrigation Solution

Drug: OMS302

2

ACTIVE COMPARATOR

OMS302-PE HCl Irrigation Solution

Drug: OMS302-PE

3

PLACEBO COMPARATOR

Standard topical mydriatics and BSS Irrigation Solution

Drug: Vehicle

Interventions

OMS302 DRUG

OMS302 Irrigation Solution

Also known as: OMS302 Irrigation Solution

1

OMS302-PE DRUG

OMS302-PE HCI Irrigation Solution

Also known as: OMS302-PE HCI Irrigation Solution

2

Vehicle DRUG

Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

Also known as: Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (4)

Shasta Eye Medical Group

Redding, California, 96002, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Davis Duehr Dean

Madison, Wisconsin, 53715, United States

Location

Related Publications (2)

• 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.

  PMID: 15043530 BACKGROUND

• 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.

  PMID: 14709298 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Scott Houston

  Omeros Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

US (4)