Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

Omeros

Status and phase: Completed; Phase 2

Conditions: Cataract

Treatments: Drug: OMS302 Mydriatic Solution; Drug: OMS302 Solution; Drug: OMS302 Anti-inflammatory Solution; Drug: Balanced Salt Solution (BSS) Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193127

C09-001

Details and patient eligibility

About

The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Competent and willing to voluntarily provide informed consent
• 18 years of age or older
• In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
• Other inclusion criteria to be evaluated by the investigator

Exclusion criteria

• No allergies to the medications and/or the active ingredients of any of the study medications
• No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
• No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
• Other exclusion criteria to be evaluated by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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223 participants in 4 patient groups, including a placebo group

OMS302 Solution

Experimental group

Description:

OMS302 Solution

Treatment:

Drug: OMS302 Solution

OMS302 Mydriatic Solution

Experimental group

Description:

OMS302 Mydriatic Solution

Treatment:

Drug: OMS302 Mydriatic Solution

OMS302 Anti-inflammatory Solution

Experimental group

Description:

OMS302 Anti-inflammatory Solution

Treatment:

Drug: OMS302 Anti-inflammatory Solution

Balanced Salt Solution (BSS) Solution

Placebo Comparator group

Description:

Balanced Salt Solution (BSS) Solution

Treatment:

Drug: Balanced Salt Solution (BSS) Solution