Trial Outcomes & Findings for Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1 (NCT NCT03888469)

Last Updated: 2020-06-25

Results Overview

Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

Day 8, each product

Results posted on

2020-06-25

Participant Flow

This study was performed at 5 study centers in the United States (US).

This reporting group includes all randomized subjects (92).

Participant milestones

Participant milestones
Measure	DDT2, Then 1DAVM Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.	1DAVM, Then DDT2 Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
First Wear Period (8 -1/+2 Days) STARTED	46	46
First Wear Period (8 -1/+2 Days) COMPLETED	46	46
First Wear Period (8 -1/+2 Days) NOT COMPLETED	0	0
Second Wear Period (8 -1/+2 Days) STARTED	46	46
Second Wear Period (8 -1/+2 Days) COMPLETED	46	46
Second Wear Period (8 -1/+2 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DDT2, Then 1DAVM n=46 Participants Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.	1DAVM, Then DDT2 n=46 Participants Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.	Total n=92 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 8.5 • n=5 Participants	31.5 years STANDARD_DEVIATION 7.8 • n=7 Participants	32.6 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	38 Participants n=7 Participants	82 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/Ethnicity, Customized White	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	46 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8, each product

Population: Full Analysis Set (FAS): All randomized subjects who were exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for optimization and fitting.

Outcome measures

Outcome measures
Measure	DDT2 n=184 eyes Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.	1DAVM n=184 eyes Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
Least Squares Mean Distance Visual Acuity With Study Lenses	-0.13 logMar Standard Error 0.008	-0.12 logMar Standard Error 0.008

Adverse Events

DDT2 - Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DDT2 - Systemic / Nonocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1DAVM - Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1DAVM - Systemic / Nonocular

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

CDMA Project Lead, Vision Care

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER