Trial Outcomes & Findings for No Drop Post-Op Cataract Surgery (NCT NCT03864133)

NCT ID: NCT03864133

Last Updated: 2023-11-30

Results Overview

Best vision will be tested with lens correction using Snellen Charts.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 94 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-11-30

Participant Flow

Participant milestones

Measure	Omidria Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Overall Study STARTED	94
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

No Drop Post-Op Cataract Surgery

Baseline characteristics by cohort

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Age, Continuous	69.7 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Best vision will be tested with lens correction using Snellen Charts.

Outcome measures

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Best Corrected Visual Acuity (BCVA) (Pre-op)	.28 LogMar Standard Deviation .2

PRIMARY outcome

Timeframe: 2 weeks

Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.

Outcome measures

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Best Corrected Visual Acuity (BCVA) (Week 2)	.18 LogMar Standard Deviation .2

PRIMARY outcome

Timeframe: 6 weeks

Best distance vision will be measured clinically to determine if improvements have been made post-operatively.

Outcome measures

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Best Corrected Visual Acuity (BCVA) (Week 6)	.11 LogMar Standard Deviation .2

PRIMARY outcome

Timeframe: 2 weeks

The number of participants that develop CME will be recorded to evaluate if Omidria is sufficient in controlling CME. The presence of CME will be determined clinically.

Outcome measures

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Number of Participants That Develop Presence of Cystoid Macular Edema (CME)	0 Participants

PRIMARY outcome

Timeframe: Baseline and week 6

The thickness of the macula will be measured pre and post operatively using ocular imaging to determine if Omidria is sufficient in controlling thickening post-operatively - measured in number of Microns

Outcome measures

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Change From Baseline in Macular Thickness Measurement - Number in Microns	12 Number of Microns Standard Deviation 0.2

PRIMARY outcome

Timeframe: Post-op weeks 1 through 6

Need for topical NSAID (rescue med) will be assessed at all post-op visits. If at any time the patient shows signs of cystoid macular edema, inflammation or pain, NSAIDs will be administered. The number of patients needing NSAID post-operatively will help determine if NSAIDS are needed.

Outcome measures

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Number of Participants Needing NSAID Post-operatively Week 1	0 Participants
Number of Participants Needing NSAID Post-operatively Week 2	0 Participants
Number of Participants Needing NSAID Post-operatively Week 3	0 Participants
Number of Participants Needing NSAID Post-operatively Week 4	3 Participants
Number of Participants Needing NSAID Post-operatively Week 5	0 Participants
Number of Participants Needing NSAID Post-operatively Week 6	5 Participants

PRIMARY outcome

Timeframe: Week 6

Anterior chamber cells will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery.

Range and meaning (if score/scale): 0-2 0 = no cell

1. = 10-20 cells

2. = greater than 20 cells

Outcome measures

Measure	Omidria n=94 Participants Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Change in Anterior Chamber Cells From Baseline Measurement	.08 Cell Score - Score on a Scale Standard Deviation 0.2

Adverse Events

Omidria

Serious events: 1 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omidria n=94 participants at risk Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Eye disorders Blindness	1.1% 1/94 • Number of events 1 • Week 6

Other adverse events

Measure	Omidria n=94 participants at risk Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Eye disorders photophobia	100.0% 94/94 • Number of events 94 • Week 6

Additional Information

Keith Walter, MD

Wake Forest University Health Sciences

Phone: 336-716-3937

Email: kwalter@wakehealth.edu

Results disclosure agreements

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