MedDataX Logo

Trial Outcomes & Findings for Comparison of Two Daily Disposable Lenses (NCT NCT04013789)

NCT ID: NCT04013789

Last Updated: 2020-11-24

Results Overview

VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

Week 1, each product

Results posted on

2020-11-24

Participant Flow

The study was conducted at a single investigative site in the United States.

Of the 79 enrolled subjects, 11 were screen failures and 1 withdrew prior to randomization. This reporting group includes all randomized subjects (67).

Participant milestones

Participant milestones
Measure
DACP FreshTech, Then DACP
DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.
DACP, Then DACP FreshTech
DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.
First Wear Period (1 Week)
STARTED
33
34
First Wear Period (1 Week)
COMPLETED
33
34
First Wear Period (1 Week)
NOT COMPLETED
0
0
Second Wear Period (1 Week)
STARTED
32
34
Second Wear Period (1 Week)
COMPLETED
32
34
Second Wear Period (1 Week)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Daily Disposable Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=67 Participants
DACP FreshTech contact lenses and DACP contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Age, Continuous
22.4 years
STANDARD_DEVIATION 3.7 • n=93 Participants
Sex: Female, Male
Female
57 Participants
n=93 Participants
Sex: Female, Male
Male
10 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
62 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
8 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
Race (NIH/OMB)
White
54 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=93 Participants

PRIMARY outcome

Timeframe: Week 1, each product

Population: Full Analysis Set: All randomized subjects (as randomized) who were exposed to any study lenses, not including the optimized habitual and trial fit lenses.

VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Outcome measures

Outcome measures
Measure
DACP FreshTech
n=66 Participants
DACP FreshTech contact lenses worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day
DACP
n=66 Participants
DACP contact lenses worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day
Mean Distance Visual Acuity (VA) With Study Lenses
-0.20 logMAR
Standard Deviation 0.06
-0.22 logMAR
Standard Deviation 0.05

Adverse Events

DACP FreshTech - Ocular

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DACP FreshTech - Systemic / Nonocular

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DACP - Ocular

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DACP - 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

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