- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02093689
Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
March 7, 2018 updated by: Omeros Corporation
A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter in Subjects at High Risk of Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
OMS302 is a mydriatic/anti-inflammatory combination investigational drug product being developed for use during intraoperative lens replacement (ILR).
This study evaluates the effect of OMS302 on the signs of Floppy Iris Syndrome in subjects with a history of tamsulosin exposure who are undergoing ILR.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Competent to provide informed consent.
- Voluntarily provide informed consent and HIPAA Authorization in accordance with local regulations and governing IEC/IRB requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
- Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions.
- Are male and 18 years of age or older at the time of surgery.
- Are to undergo unilateral primary ILR, under topical anesthesia, with insertion of an intraocular lens.
- Have a best-corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.
- Have an intraocular pressure (IOP) between 5 mm Hg and 22 mm Hg, inclusive, in the study eye.
- Is currently and has been taking tamsulosin (Flomax®) for at least six months.
Exclusion Criteria:
- Hypersensitivity to phenylephrine, ketoprofen, bromfenac, or other NSAIDs, including aspirin.
- Hypersensitivity to tetracaine, lidocaine, ophthalmic viscoelastic devices (such as hydroxypropylmethylcellulose or hyaluronic acid or latex..
- Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory or other medical condition that could increase the risk to the subject as determined by the Investigator.
- Presence of any connective tissue disorder (e.g., lupus, rheumatoid arthritis, fibromyalgia).
- Presence of systolic blood pressure of greater than 170 mmHg or less than 90 mmHg, or diastolic blood pressure of greater than110 mmHg or less than 40 mmHg at the screening visit.
- Use of phenylephrine in the study eye (other than for the screening ophthalmological examination) within seven days prior to the day of surgery.
- Use of monoamine oxidase inhibitors within 21 days prior to the day of surgery.
- Use of pilocarpine in the study eye within seven days prior to the day of surgery.
- Presence of narrow-angle glaucoma or unstable glaucoma.
- Glaucoma being treated with prostaglandins or prostaglandin analogues such as Xalatan®, Lumigan®, Travatan®, and Rescula®, or Alphagan® (brimonidine tartrate) in either eye during the seven days prior to screening and through Day 7 postoperatively.
- Presence of pseudo-capsular exfoliation in either eye.
- History of iritis, or of any ocular trauma with iris damage in the study eye.
- Presence of uncontrolled chronic ocular diseases in either eye that could affect pupil dilation.
- Presence of active corneal pathology in either eye (except superficial punctate keratopathy in the non-study eye).
- Presence of extraocular/intraocular inflammation in either eye.
- Presence of active bacterial and/or viral infection in either eye.
- Participating in any investigational drug or device trial within the 30 days prior to the day of surgery.
- History of intraocular non-laser surgery in the study eye within the three months prior to the day of surgery, or intraocular laser surgery in the study eye within 30 days prior to the day of surgery.
- Presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of the study data.
- Investigators, employees of the investigative site, and their immediate families. Immediate family is defined as the Investigator's or employees' current spouse, parent, natural or legally adopted child (including a stepchild living in the Investigator's household), grandparent, or grandchild.
- Prior participation in a clinical study of OMS302.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1 OMS302
OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
|
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 (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5).
For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.
|
Experimental: Part 2 OMS302
OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
|
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 (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5).
For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.
|
Placebo Comparator: Part 2 Placebo
Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution.
|
Placebo drug product is 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, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pupil Diameter
Time Frame: Intraoperative
|
Change in pupil diameter over time from surgical baseline to the end of the surgical procedure determined by video capture during ILR.
|
Intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Steve Whitaker, MD, Omeros Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
March 18, 2014
First Submitted That Met QC Criteria
March 19, 2014
First Posted (Estimate)
March 21, 2014
Study Record Updates
Last Update Posted (Actual)
March 13, 2018
Last Update Submitted That Met QC Criteria
March 7, 2018
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMS302-ILR-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intraocular Lens Replacement
-
Omeros CorporationCompletedIntraocular Lens ReplacementUnited States
-
Omeros CorporationCompletedIntraocular Lens ReplacementUnited States, Netherlands
-
University Hospital AugsburgRecruitingIntraocular Lens Rotation | Lens Opacities | Intraocular Lens Associated Postoperative Inflammation | Intraocular Lens ComplicationGermany
-
Medical University of ViennaCompleted
-
Faculty Hospital Kralovske VinohradySomich, s.r.o.; Očni centrum Praha a.s.Recruiting
-
Taipei Nobel Eye ClinicCompleted
-
Faculty Hospital Kralovske VinohradyRecruitingIntraocular LensCzechia, Slovakia
-
Aier School of Ophthalmology, Central South UniversityUnknown
-
Medicontur Medical Engineering LtdActive, not recruitingCataract | Pseudophakia | Intraocular Lens Complication | Intraocular Lens OpacificationHungary
-
Eyebright Medical Technology (Beijing) Co., Ltd.CompletedIntraocular Lens Implantation
Clinical Trials on Part 1 OMS302
-
Novartis PharmaceuticalsCompletedPrimary Biliary CholangitisUnited States, Germany, Russian Federation, Canada, United Kingdom, Poland
-
PfizerCompletedRheumatoid Arthritis | Healthy VolunteersUnited States
-
Ichnos Sciences SAGlenmark Pharmaceuticals S.A.CompletedModerate to Severe Atopic DermatitisUnited States, Canada, Czechia, Germany, Poland
-
Chiesi Farmaceutici S.p.A.CompletedCystic Fibrosis | Non-Cystic Fibrosis BronchiectasisBelgium
-
Janssen Research & Development, LLCCompletedHealthy | Asthma | Atopic DermatitisGermany, Belgium
-
Janssen Research & Development, LLCPharmacyclics LLC.CompletedCD20-positive B-cell Non-Hodgkin LymphomaUnited States, France
-
Akesobio Australia Pty LtdCompletedAtopic DermatitisNew Zealand, Australia
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)Completed
-
Sun Pharma Advanced Research Company LimitedTerminatedAdvanced Breast Cancer | HER2-negative Breast Cancer | Hormone Receptor-positive Breast CancerUnited States, India
-
AstraZenecaAcerta Pharma, LLCCompletedBioavailability | B-cell Lymphoid CancerUnited States