Trial Outcomes & Findings for Assessing Fitting Guides in Alcon Multifocal Contact Lenses (NCT NCT03118934)

NCT ID: NCT03118934

Last Updated: 2018-09-26

Results Overview

The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit

Recruitment status

COMPLETED

Study phase

Target enrollment

188 participants

Primary outcome timeframe

VIsit 1/Day 1

Results posted on

2018-09-26

Participant Flow

Subjects were recruited from 20 investigational sites located in the United States (14), United Kingdom (3), and Canada (3).

Of the 188 enrolled subjects, 6 were exited prior to trial fit. This reporting group includes all subjects randomized and trial fit, as randomized (182). Safety Analysis Set is reported as exposed.

Participant milestones

Participant milestones
Measure	AOA MF - Alternative Bilaterally (in both eyes) fitted using alternative fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days	DACP MF - Alternative Bilaterally fitted using alternative fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	DT1 MF - Alternative Bilaterally fitted using alternative fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	AOA MF - Current Bilaterally fitted using current fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days	DACP MF - Current Bilaterally fitted using current fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	DT1 MF - Current Bilaterally fitted using current fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Overall Study STARTED	34	31	34	29	29	25
Overall Study Safety Analysis Set	34	29	34	29	26	25
Overall Study COMPLETED	34	30	33	28	27	23
Overall Study NOT COMPLETED	0	1	1	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DACP MF - Alternative Bilaterally fitted using alternative fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	DT1 MF - Alternative Bilaterally fitted using alternative fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	AOA MF - Current Bilaterally fitted using current fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days	DACP MF - Current Bilaterally fitted using current fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	DT1 MF - Current Bilaterally fitted using current fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Overall Study Adverse Event	0	0	0	0	1
Overall Study Physician Decision	0	0	0	0	1
Overall Study Discontinued prior to exposure	1	1	1	2	0

Baseline Characteristics

Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AOA MF n=63 Participants Lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days	DACP MF n=55 Participants Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	DT1 MF n=59 Participants Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Total n=177 Participants Total of all reporting groups
Age, Continuous	50.6 years STANDARD_DEVIATION 6.9 • n=5 Participants	50.1 years STANDARD_DEVIATION 6.7 • n=7 Participants	50.1 years STANDARD_DEVIATION 6.7 • n=5 Participants	50.3 years STANDARD_DEVIATION 6.7 • n=4 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	46 Participants n=7 Participants	52 Participants n=5 Participants	149 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	28 Participants n=4 Participants
Race/Ethnicity, Customized White	55 Participants n=5 Participants	48 Participants n=7 Participants	51 Participants n=5 Participants	154 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: VIsit 1/Day 1

Population: This analysis population includes all subjects randomized or assigned to study lenses as applicable, and exposed to study lenses including trial fit at Visit 1 (Full Analysis Set).

The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit