CompletedNCT03567005Updated Jun 18, 2019Results posted

Clinical Validation of DACP Digital Design

An interventional study of Nelfilcon A digital contact lenses and Nelfilcon A contact lenses in Refractive Errors, sponsored by Alcon Research. Completed at 5 sites in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-06-18.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 35 Years
Sex: All

Study summary

The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.

Conditions studied

Refractive Errors

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Refractive Errors 427

In context

Refractive Errors

427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 60 is below the median of 81 across 307 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.

Browse Alcon Research studies →All Alcon studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Willing and able to sign an IRB/IEC approved Informed Consent form;
Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
Experiencing symptoms of eye strain from using technology;
Willing to wear study lenses each day;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
Willing to NOT use rewetting/lubricating drops at any time during the study;
Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Exclusion criteria

Exclusion Criteria:

Conditions, use of medications, injury, or surgery, as specified in the protocol;
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Monocular (only one eye with functional vision);
Pregnant.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 60 participants (actual)

Study arms

Other
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.
Device: Nelfilcon A digital contact lenses · Device: Nelfilcon A contact lenses
Other
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.
Device: Nelfilcon A digital contact lenses · Device: Nelfilcon A contact lenses

Interventions

DeviceNelfilcon A digital contact lenses
Silicone hydrogel digital contact lenses
Also known as: DAILIES® AquaComfort Plus® Digital, DACP Digital
DeviceNelfilcon A contact lenses
Silicone hydrogel spherical contact lenses
Also known as: DAILIES® AquaComfort Plus®, DACP

What researchers measure

Primary outcomes

Distance Visual Acuity (VA) (logMAR, OU)
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.
Time frame: Day 7, each product

Secondary outcomes

Overall Vision
Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.
Time frame: Day 7, each product

Results

Posted Jun 18, 2019

Participant flow

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

Period 1, First 7 Days of Wear

Participant flow — Period 1, First 7 Days of Wear
Milestone	DACP Digital Then DACP	DACP Then DACP Digital
Started	29	31
Completed	29	31
Not completed	0	0

Period 2, Second 7 Days of Wear

Participant flow — Period 2, Second 7 Days of Wear
Milestone	DACP Digital Then DACP	DACP Then DACP Digital
Started	29	31
Completed	29	31
Not completed	0	0

Outcome measures

PrimaryDistance Visual Acuity (VA) (logMAR, OU)

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.

Time frame:: Day 7, each product
Reported as:: Mean · logMAR

Distance Visual Acuity (VA) (logMAR, OU)
logMAR	DACP Digital	DACP
Distance Visual Acuity (VA) (logMAR, OU)	-0.11 ± 0.10	-0.12 ± 0.09

Statistical analysis

DACP Digital vs DACP · Least squares mean (lsm) difference: 0.00

SecondaryOverall Vision

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

Time frame:: Day 7, each product
Reported as:: Mean · units on a scale

Overall Vision
units on a scale	DACP Digital	DACP
Overall Vision	8.8 ± 1.0	8.9 ± 1.0

Statistical analysis

DACP Digital vs DACP · Lsm difference: -0.0

Adverse events

Collected over Dispense through study completion, an average of 14 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DACP Digital	0/60 (0%)	0/60 (0%)	0/60 (0%)
DACP	0/60 (0%)	0/60 (0%)	0/60 (0%)

Baseline characteristics

This analysis population includes all randomized subjects who were exposed to any study lenses evaluated in this study (Full Analysis Set).

Age, Continuous
Age, Continuous(years)	Overall
Mean	25.2 ± 5.3

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	36
Male	24

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Overall
White	56
Black or African American	3
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Other	1

Study locations

5 sites

Alcon Investigative Site
Bloomington, Illinois 61701, United States
Alcon Investigative Site
Powell, Ohio 43065, United States
Alcon Investigative Site
Brentwood, Tennessee 37027, United States
Alcon Investigative Site
Memphis, Tennessee 38104, United States
Alcon Investigative Site
Memphis, Tennessee 38111, United States

References and documents

Study documents

Study protocol · Jul 16, 2018
Statistical analysis plan · Jul 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Aug 2018, 2 months.

Results were first posted in Jun 2019, 9 months after primary completion.

Of 122 industry-sponsored interventional studies with no phase under Refractive Errors, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 10. This study's 2 months is below that.

Counting every sponsor, half of 174 studies reached it within 7 months; a quarter within 2 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 13, 2018
First posted: Jun 25, 2018
StartActual: Jun 25, 2018
Primary completionActual: Aug 26, 2018
CompletionActual: Aug 26, 2018
Results first posted: Jun 18, 2019
Last update: Jun 18, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03567005
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Jun 25, 2018
Start date: Jun 25, 2018
Primary completion: Aug 26, 2018
Completion: Aug 26, 2018
Results posted: Jun 18, 2019
Last update: Jun 18, 2019

Study contacts

Alcon Research

study director · Alcon Research

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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