Trial Outcomes & Findings for Clinical Validation of DACP Digital Design (NCT NCT03567005)

Last Updated: 2019-06-18

Results Overview

VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Day 7, each product

Results posted on

2019-06-18

Participant Flow

Subjects were recruited from 5 investigative sites located in the United States.

All 60 enrolled subjects were randomized and exposed to the investigational products.

Participant milestones

Participant milestones
Measure	DACP Digital Then DACP Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.	DACP Then DACP Digital Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.
Period 1, First 7 Days of Wear STARTED	29	31
Period 1, First 7 Days of Wear COMPLETED	29	31
Period 1, First 7 Days of Wear NOT COMPLETED	0	0
Period 2, Second 7 Days of Wear STARTED	29	31
Period 2, Second 7 Days of Wear COMPLETED	29	31
Period 2, Second 7 Days of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Validation of DACP Digital Design

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=60 Participants Nelfilcon A digital contact lenses and nelfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Age, Continuous	25.2 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7, each product

Population: Full Analysis Set with non-missing response

Outcome measures

Outcome measures
Measure	DACP Digital n=60 Participants Nelfilcon A digital contact lenses worn bilaterally for 7 days in a daily disposable modality.	DACP n=58 Participants Nelfilcon A contact lenses worn bilaterally for 7 days in a daily disposable modality.
Distance Visual Acuity (VA) (logMAR, OU)	-0.11 logMAR Standard Deviation 0.10	-0.12 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: Day 7, each product

Population: Full Analysis Set with non-missing response

Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure	DACP Digital n=59 Participants Nelfilcon A digital contact lenses worn bilaterally for 7 days in a daily disposable modality.	DACP n=60 Participants Nelfilcon A contact lenses worn bilaterally for 7 days in a daily disposable modality.
Overall Vision	8.8 units on a scale Standard Deviation 1.0	8.9 units on a scale Standard Deviation 1.0

Adverse Events

DACP Digital

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DACP

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

Alcon Research

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