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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT01579565
First received: April 13, 2012
Last updated: July 10, 2013
Last verified: July 2013

April 13, 2012
July 10, 2013
April 2012
November 2012   (final data collection date for primary outcome measure)
  • Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Change in pupil diameter over time from surgical baseline to end of the surgical procedure determined by video capture during ILR.
  • Pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Postoperative pain as measured by the Visual Analog Scale at 2, 4, 6, 8 and 10-12 hours after ILR surgery.
Same as current
Complete list of historical versions of study NCT01579565 on ClinicalTrials.gov Archive Site
  • Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Proportion of subjects having a pupil diameter >= 6mm at cortical clean-up.
  • Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Proportion of subjects having a pupil diameter < 6mm anytime during surgery.
  • Moderate-to-severe pain pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Proportion of subjects reporting moderate-to-severe pain at any timepoints during 12 hours postoperatively.
  • No Pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Proportion of subjects reporting no pain at all timepoints during 12 hours postoperatively.
  • Pain during the late postoperative period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Postoperative pain as measured by the Visual Analog Scale at 24 and 48 hours, and Days 3-7 and 14 after ILR surgery.
  • Safety as measured by adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Safety as assessed by the incidence of adverse events and serious adverse events through day 90.
  • Postoperative photophobia [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Photophobia as measured by the photophobia scale of the NRS at 2, 6, 24, and 48 hours, and 7 and 14 days after surgery.
  • Postoperative best-corrected visual acuity (BVCA) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    BVCA as measured using the Early Treatment Diabetic Retinopathy Study method at 24 and 48 hours, and 7, 14 and 90 days after surgery.
  • Postoperative inflammation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Postoperative inflammation as measured using the Summed Ocular Inflammation Score at 24 and 48 hours, and 7, 14 and 90 days after surgery.
  • Systemic Pharmacokinetics of OMS302 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Pharmacokinetics will be evaluated using plasma concentrations of OMS302 at baseline and at approximately 15 and 30 minutes and 1, 2, 4, 8 and 24 hours following initiation of study drug administration.
  • Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Proportion of subjects having a pupil diameter >= 6mm at cortical clean-up.
  • Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Proportion of subjects having a pupil diameter < 6mm anytime during surgery.
  • Moderate-to-severe pain pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Proportion of subjects reporting moderate-to-severe pain at any timepoints during 12 hours postoperatively.
  • No Pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Proportion of subjects reporting no pain at all timepoints during 12 hours postoperatively.
  • Pain during the late postoperative period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Postoperative pain as measured by the Visual Analog Scale at 24 and 48 hours, and Days 3-7 and 14 after ILR surgery.
  • Safety as measured by adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Safety as assessed by the incidence of adverse events and serious adverse events through day 90.
  • Postoperative photophobia [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Photophobia as measured by the photophobia scale of the NRS at 2, 6, 24, and 48 hours, and 7 and 14 days after surgery.
  • Postoperative best-corrected visual acuity (BVCA) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    BVCA as measured using the Early Treatment Diabetic Retinopathy Study method at 24 and 48 hours, and 7, 14 and 90 days after surgery.
  • Postoperative inflammation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Postoperative inflammation as measured using the Summed Ocular Inflammation Score at 24 and 48 hours, and 7, 14 and 90 days after surgery.
  • Systemic Pharmacokinetics of PE and KE [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Pharmacokinetics will be evaluated using plasma concentrations of PE and KE at baseline and at approximately 15 and 30 minutes and 1, 2, 4, 8 and 24 hours following initiation of study drug administration.
Not Provided
Not Provided
 
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS32 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intraocular Lens Replacement
  • Drug: OMS302
    OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS solution.
  • Drug: Placebo
    Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS solution.
  • Experimental: OMS302
    OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
    Intervention: Drug: OMS302
  • Placebo Comparator: Placebo
    Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
416
January 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT01579565
OMS302-ILR-004
No
Omeros Corporation
Omeros Corporation
Not Provided
Study Director: Steve Whitaker, MD Omeros Corporation
Omeros Corporation
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP