NCT03567005

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 18, 2019

Completed
Last Updated

June 18, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

June 13, 2018

Results QC Date

May 28, 2019

Last Update Submit

May 28, 2019

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 7, each product

Secondary Outcomes (1)

  • Overall Vision

    Day 7, each product

Study Arms (2)

DACP Digital then DACP

OTHER

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 lensesDevice: Nelfilcon A contact lenses

DACP then DACP Digital

OTHER

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 lensesDevice: Nelfilcon A contact lenses

Interventions

Nelfilcon A digital contact lensesDEVICE

Silicone hydrogel digital contact lenses

Also known as: DAILIES® AquaComfort Plus® Digital, DACP Digital
DACP Digital then DACPDACP then DACP Digital
Nelfilcon A contact lensesDEVICE

Silicone hydrogel spherical contact lenses

Also known as: DAILIES® AquaComfort Plus®, DACP
DACP Digital then DACPDACP then DACP Digital

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Alcon Investigative Site

Bloomington, Illinois, 61701, United States

Location

Alcon Investigative Site

Powell, Ohio, 43065, United States

Location

Alcon Investigative Site

Brentwood, Tennessee, 37027, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38104, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
CDMA Project Lead
Organization
Alcon Research
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Alcon Research

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

June 25, 2018

Study Start

June 25, 2018

Primary Completion

August 26, 2018

Study Completion

August 26, 2018

Last Updated

June 18, 2019

Results First Posted

June 18, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(5)