Trial Outcomes & Findings for Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery (NCT NCT02093689)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

Intraoperative

Results posted on

2018-03-13

Part 2 of the study was not performed.

Participant milestones
Measure	Part 1 OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Part 2 OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Part 2 Placebo Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.
Overall Study STARTED	18	0	0
Overall Study COMPLETED	14	0	0
Overall Study NOT COMPLETED	4	0	0

Reasons for withdrawal
Measure	Part 1 OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Part 2 OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Part 2 Placebo Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.
Overall Study Physician Decision	4	0	0

Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery

Baseline characteristics by cohort
Measure	Part 1 OMS302 n=14 Participants OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Part 2 OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution	Part 2 Placebo Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	—	—	14 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	14 Participants n=4 Participants

Timeframe: Intraoperative

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

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

Outcome data not reported

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Part 1 OMS302 n=14 participants at risk OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
Eye disorders Zonulolysis	7.1% 1/14 • Number of events 1 • AEs are collected from time of informed consent through study completion, up to 7 days.
Eye disorders Intraocular pressure increased	14.3% 2/14 • Number of events 2 • AEs are collected from time of informed consent through study completion, up to 7 days.
Eye disorders Iridocele	7.1% 1/14 • Number of events 1 • AEs are collected from time of informed consent through study completion, up to 7 days.

Omeros Corporation

Phone: 206-676-5000

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER