Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery

• Sponsor: Omeros Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02093689
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arms: 3
• Duration (Months): 5.9
• Patients Per Site: 9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Lens Replacement; Intraoperative Floppy Iris Syndrome	Drug: Part 1 OMS302; Drug: Part 2 OMS302; Drug: Part 2 Placebo	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Drug: Part 1 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 (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	Drug: Part 2 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 (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.	Drug: Part 2 Placebo; 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.

Outcome Measures

Primary Outcome Measures

1. Change in Pupil Diameter [Intraoperative]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Competent to provide informed consent.

2. 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.

3. Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions.

4. Are male and 18 years of age or older at the time of surgery.

5. Are to undergo unilateral primary ILR, under topical anesthesia, with insertion of an intraocular lens.

6. Have a best-corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.

7. Have an intraocular pressure (IOP) between 5 mm Hg and 22 mm Hg, inclusive, in the study eye.

8. Is currently and has been taking tamsulosin (Flomax®) for at least six months.

Exclusion Criteria:

1. Hypersensitivity to phenylephrine, ketoprofen, bromfenac, or other NSAIDs, including aspirin.

2. Hypersensitivity to tetracaine, lidocaine, ophthalmic viscoelastic devices (such as hydroxypropylmethylcellulose or hyaluronic acid or latex..

3. 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.

4. Presence of any connective tissue disorder (e.g., lupus, rheumatoid arthritis, fibromyalgia).

5. 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.

6. Use of phenylephrine in the study eye (other than for the screening ophthalmological examination) within seven days prior to the day of surgery.

7. Use of monoamine oxidase inhibitors within 21 days prior to the day of surgery.

8. Use of pilocarpine in the study eye within seven days prior to the day of surgery.

9. Presence of narrow-angle glaucoma or unstable glaucoma.

10. 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.

11. Presence of pseudo-capsular exfoliation in either eye.

12. History of iritis, or of any ocular trauma with iris damage in the study eye.

13. Presence of uncontrolled chronic ocular diseases in either eye that could affect pupil dilation.

14. Presence of active corneal pathology in either eye (except superficial punctate keratopathy in the non-study eye).

15. Presence of extraocular/intraocular inflammation in either eye.

16. Presence of active bacterial and/or viral infection in either eye.

17. Participating in any investigational drug or device trial within the 30 days prior to the day of surgery.

18. 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.

19. Presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of the study data.

20. 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.

21. Prior participation in a clinical study of OMS302.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Omeros Investigational Site	Vienna		Austria
2	Omeros Investigational Site	Bochum		Germany

Sponsors and Collaborators

• Omeros Corporation

Investigators

• Study Director: Steve Whitaker, MD, Omeros Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omeros Corporation
• ClinicalTrials.gov Identifier: NCT02093689
• Other Study ID Numbers: OMS302-ILR-006
• First Posted: Mar 21, 2014
• Last Update Posted: Mar 13, 2018
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Syndrome

Study Results

Participant Flow

Pre-assignment Detail	Part 2 of the study was not performed.

Arm/Group Title	Part 1 OMS302	Part 2 OMS302	Part 2 Placebo
Arm/Group Description	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.
Period Title: Overall Study
STARTED	18	0	0
COMPLETED	14	0	0
NOT COMPLETED	4	0	0

Baseline Characteristics

Arm/Group Title	Part 1 OMS302	Part 2 OMS302	Part 2 Placebo	Total
Arm/Group Description	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.	Total of all reporting groups
Overall Participants	14	0	0	14
Age (Count of Participants)
<=18 years	0 0%	0 NaN
Between 18 and 65 years	0 0%	0 NaN
>=65 years	14 100%	14 Infinity
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN	0 NaN	0 0%
Male	14 100%	0 NaN	0 NaN	14 100%

Outcome Measures

1. Primary Outcome

Title	Change in Pupil Diameter
Description	Change in pupil diameter over time from surgical baseline to the end of the surgical procedure determined by video capture during ILR.
Time Frame	Intraoperative

Outcome Measure Data

Analysis Population Description

Pupil measurement methodology determined not to be appropriate in this population and data were not analyzed from any participant.

Arm/Group Title	Part 1 OMS302	Part 2 OMS302	Part 2 Placebo
Arm/Group Description	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution.
Measure Participants	0	0	0

Adverse Events

Time Frame	AEs are collected from time of informed consent through study completion, up to 7 days.
Arm/Group Title	Part 1 OMS302
Arm/Group Description	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
All Cause Mortality
	Part 1 OMS302
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Part 1 OMS302
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Part 1 OMS302
	Affected / at Risk (%)	# Events
Total	3/14 (21.4%)
Eye disorders
Zonulolysis	1/14 (7.1%)	1
Intraocular pressure increased	2/14 (14.3%)	2
Iridocele	1/14 (7.1%)	1

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The data resulting from the Study was to be made public by the sponsor at the end of the study after all results were available and analyzed, with a report on the study to have been prepared in consultation with the PI, rather than being published by the PI.