Trial Outcomes & Findings for Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo (NCT NCT03025945)

Results Overview

post-operative macular volume (mm)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

662 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-12-14

Participant milestones
Measure	Nepafenac 0.3% nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%	Saline Solution sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution
Overall Study STARTED	331	331
Overall Study COMPLETED	331	331
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

Baseline characteristics by cohort
Measure	Nepafenac 0.3% n=500 Eyes nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%	Saline Solution n=500 Eyes sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution	Total n=1000 Eyes Total of all reporting groups
Age, Continuous	68.8 years n=5 Participants	67.9 years n=7 Participants	68.3 years n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants	182 Participants n=7 Participants	364 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	149 Participants n=7 Participants	298 Participants n=5 Participants
Macular volume	8.7 mm STANDARD_DEVIATION 0.15 • n=5 Participants	8.75 mm STANDARD_DEVIATION 0.15 • n=7 Participants	8.72 mm STANDARD_DEVIATION 0.15 • n=5 Participants

Timeframe: 6 weeks

post-operative macular volume (mm)

Outcome measures
Measure	Nepafenac 0.3% n=500 Eyes nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%	Saline Solution n=500 Eyes sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution
Post-operative Clinical Findings of Cystoid Macular Edema	8.85 mm Standard Deviation 0.13	8.95 mm Standard Deviation 0.18

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Nepafenac 0.3% n=331 participants at risk nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%	Saline Solution n=331 participants at risk sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution
Eye disorders drop intolerance	0.30% 1/331 • Number of events 1 • 3 weeks Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/331 • 3 weeks Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

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