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: August 5, 2014
Last verified: August 2014
Results First Received: July 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Intraocular Lens Replacement
Interventions: Drug: OMS302
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OMS302

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

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 of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.

Placebo

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

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 of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.


Participant Flow for 2 periods

Period 1:   Randomized
    OMS302     Placebo  
STARTED     207     209  
COMPLETED     202     204  
NOT COMPLETED     5     5  
Adverse Event                 1                 3  
Withdrawal by Subject                 3                 0  
inadequate preoperative pupil dilation                 0                 1  
prohibited preoperative eating                 1                 0  
prohibited preoperative medication                 0                 1  

Period 2:   Treated
    OMS302     Placebo  
STARTED     202     204  
COMPLETED     200     201  
NOT COMPLETED     2     3  
Physician Decision                 0                 1  
Lost to Follow-up                 2                 1  
declined to return for final visit                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OMS302

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

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 of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.

Placebo

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

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 of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.

Total Total of all reporting groups

Baseline Measures
    OMS302     Placebo     Total  
Number of Participants  
[units: participants]
  202     204     406  
Age  
[units: years]
Mean ± Standard Deviation
  69.2  ± 9.2     67.5  ± 10.6     68.3  ± 10.0  
Gender  
[units: participants]
     
Female     117     126     243  
Male     85     78     163  



  Outcome Measures
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1.  Primary:   Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery   [ Time Frame: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure) ]

2.  Primary:   Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively   [ Time Frame: 12 hours postoperatively ]

3.  Secondary:   Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up   [ Time Frame: at time of cortical clean-up (i.e., end of surgical procedure) ]

4.  Secondary:   Pupil Diameter Less Than 6 mm Anytime During Surgery   [ Time Frame: Intraoperative ]

5.  Secondary:   Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively   [ Time Frame: 12 hours postoperatively ]

6.  Secondary:   Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively   [ Time Frame: 12 hours postoperatively ]

7.  Secondary:   Ocular Pain VAS Score on Day 1   [ Time Frame: One day postoperatively ]

8.  Secondary:   Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 6 Hours Post-Surgery   [ Time Frame: Six hours postoperatively ]

9.  Secondary:   Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 1 Day Post-Surgery   [ Time Frame: One day postoperatively ]

10.  Secondary:   Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1   [ Time Frame: One day postoperatively ]

11.  Secondary:   Postoperative Best Corrected Visual Acuity (BVCA) on Day 1   [ Time Frame: One day postoperatively ]

12.  Secondary:   Systemic Pharmacokinetics (PK) of OMS302   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Omeros Corporation
phone: (206) 676-5000
e-mail: swhitaker@omeros.com


No publications provided


Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT01579565     History of Changes
Other Study ID Numbers: OMS302-ILR-004
Study First Received: April 13, 2012
Results First Received: July 2, 2014
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care