Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification (OMS302-ILR-004)

Omeros

Status and phase: Completed; Phase 3

Conditions: Intraocular Lens Replacement

Treatments: Drug: OMS302; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579565

OMS302-ILR-004

Details and patient eligibility

About

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

Enrollment: 416 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 or lens extraction with lens replacement surgery in one eye, under topical anesthesia

Exclusion criteria

• No allergies to the medications and/or the active ingredients of any of the study medications
• No medications with the same activities 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 2 patient groups, including a placebo group

OMS302

Experimental group

Description:

OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.

Treatment:

Drug: OMS302

Placebo

Placebo Comparator group

Description:

Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.

Treatment:

Drug: Placebo