Trial Outcomes & Findings for On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours (NCT NCT03881670)

NCT ID: NCT03881670

Last Updated: 2020-03-10

Results Overview

Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 0-12 hours
• Results posted on: 2020-03-10

Participant Flow

Participant milestones

Measure	Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe First intervention (2+/-1day) Second intervention (2+/-1day)	Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B First intervention (2+/-1day) Second intervention (2+/-1day)
Overall Study STARTED	12	12
Overall Study Completed First Intervention	12	12
Overall Study Completed Second Intervetion	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours

Baseline characteristics by cohort

Measure	Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe n=12 Participants First intervention (2+/-1day) Second intervention (2+/-1day)	Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B n=12 Participants First intervention (2+/-1day) Second intervention (2+/-1day)	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.25 years STANDARD_DEVIATION 3.57 • n=5 Participants	24.33 years STANDARD_DEVIATION 3.80 • n=7 Participants	24.29 years STANDARD_DEVIATION 3.61 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-12 hours

Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects

Outcome measures

Measure	Lotrafilcon B n=24 Participants All subjects (randomized, crossover design)	Lotrafilcon B With Hydraluxe n=24 Participants All subjects (randomized, crossover design)
Higher Order Aberrations	0.001646 microns Standard Deviation 0.028867	0.002629 microns Standard Deviation 0.044299

SECONDARY outcome

Timeframe: 0-12 hours

Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)

Outcome measures

Measure	Lotrafilcon B n=24 Participants All subjects (randomized, crossover design)	Lotrafilcon B With Hydraluxe n=24 Participants All subjects (randomized, crossover design)
Subjective Stability of Vision Rating	-5.833 score on a scale Standard Deviation 10.8	-2.500 score on a scale Standard Deviation 9.78

SECONDARY outcome

Timeframe: 0-12 hours

Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects

Outcome measures

Measure	Lotrafilcon B n=24 Participants All subjects (randomized, crossover design)	Lotrafilcon B With Hydraluxe n=24 Participants All subjects (randomized, crossover design)
Image Quality Metrics	0.015134 microns Standard Deviation 0.051825	0.013899 microns Standard Deviation 0.036077

Adverse Events

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon B With Hydraluxe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pete Kollbaum

IU School of Optometry

Phone: 812-856-0108

Email: kollbaum@iu.edu

Results disclosure agreements

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

Restriction type: LTE60