Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery

NCT02093689 | Terminated Phase 3 Results

• 1 other identifier: OMS302-ILR-006
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.

Conditions

Intraocular Lens Replacement; Intraoperative Floppy Iris Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Pupil Diameter

  Change in pupil diameter over time from surgical baseline to the end of the surgical procedure determined by video capture during ILR.

  Intraoperative

Study Arms (3)

Part 1 OMS302

EXPERIMENTAL

OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution

Drug: Part 1 OMS302

Part 2 OMS302

EXPERIMENTAL

OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution

Drug: Part 2 OMS302

Part 2 Placebo

PLACEBO COMPARATOR

Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution.

Drug: Part 2 Placebo

Interventions

Part 1 OMS302 DRUG

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.

Part 1 OMS302

Part 2 OMS302 DRUG

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.

Part 2 OMS302

Part 2 Placebo DRUG

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.

Part 2 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (2)

Omeros Investigational Site

Vienna, Austria

Location

Omeros Investigational Site

Bochum, Germany

Location

Limitations and Caveats

This study had 2 parts. Part 1 evaluated the feasibility of the pupil measurement methodology in this patient population. The methodology was found not to be appropriate in this population. Therefore, part 2 of the study was not conducted.

Results Point of Contact

• Title: Medical Monitor
• Organization: Omeros Corporation

info@omeros.com

206-676-5000

Study Officials

• Steve Whitaker, MD

  Omeros Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 21, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (1)