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Clinical Validation of DACP Digital Design

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nelfilcon A digital contact lenses
Nelfilcon A contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

DACP Digital then DACP

DACP then DACP Digital

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2018
Last Updated
May 28, 2019
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03567005
Brief Title
Clinical Validation of DACP Digital Design
Official Title
Clinical Validation of DACP Digital Design
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
August 26, 2018 (Actual)
Study Completion Date
August 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DACP Digital then DACP
Arm Type
Other
Arm Description
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.
Arm Title
DACP then DACP Digital
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A digital contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort Plus® Digital, DACP Digital
Intervention Description
Silicone hydrogel digital contact lenses
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort Plus®, DACP
Intervention Description
Silicone hydrogel spherical contact lenses
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) (logMAR, OU)
Description
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 Outcome Measure Information:
Title
Overall Vision
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Research
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Alcon Investigative Site
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigative Site
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Validation of DACP Digital Design

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