NCT02750813

Brief Summary

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

April 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 26, 2017

Completed
Last Updated

July 2, 2018

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

April 21, 2016

Results QC Date

July 25, 2017

Last Update Submit

May 31, 2018

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

  • Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14

    Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

    Day 14, each product

Secondary Outcomes (1)

  • Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14

    Day 14, each product

Study Arms (2)

DT1, then AO1D

OTHER

Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.

Device: Delefilcon A contact lensesDevice: Senofilcon A contact lenses

AO1D, then DT1

OTHER

Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.

Device: Delefilcon A contact lensesDevice: Senofilcon A contact lenses

Interventions

Delefilcon A contact lensesDEVICE
Also known as: DAILIES TOTAL1® (DT1)
AO1D, then DT1DT1, then AO1D
Senofilcon A contact lensesDEVICE
Also known as: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)
AO1D, then DT1DT1, then AO1D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must sign informed consent form;
  • Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
  • Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
  • Cylinder equal or lower than -0.75D in both eyes;
  • Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
  • Can be successfully fitted with both study lenses at Visit 1;
  • Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;

You may not qualify if:

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Fitted with monovision;
  • Prior refractive surgery;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Pregnant or lactating;
  • Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
  • Participation in any clinical study within 30 days of Visit 1;
  • Current DT1 or AO1D lens wearer;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Franchise Head, Vision Care
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr. Clinical Manager, Global Medical Affairs, GCRA

    Alcon, A Novartis Division

    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

April 21, 2016

First Posted

April 26, 2016

Study Start

April 27, 2016

Primary Completion

August 17, 2016

Study Completion

August 17, 2016

Last Updated

July 2, 2018

Results First Posted

September 26, 2017

Record last verified: 2017-08

Locations

US(1)