Evaluation of Delefilcon A Contact Lenses

August 19, 2026 updated by: Alcon Research

Clinical Evaluation of Overall Lens Fit of Delefilcon A Contact Lenses of Different Diameters and Base Curves

The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90013
        • Kurata Eyecare Center
      • Oakland, California, United States, 94607
        • Elsa Pao, OD
      • San Francisco, California, United States, 94127
        • Pacific Rims Optometry
    • Florida
      • Longwood, Florida, United States, 32779
        • Pearson Research Center, PA
      • Maitland, Florida, United States, 32751
        • Kindred Optics at Maitland Vision
    • Georgia
      • Dallas, Georgia, United States, 30157
        • Eyeconic Family Eyecare
    • Michigan
      • Sterling Heights, Michigan, United States, 48312
        • Dr. Schwartz Optometrist and Associates
    • Mississippi
      • Coldwater, Mississippi, United States, 38618
        • Coldwater Vision Research
    • New York
      • New York, New York, United States, 10036
        • SUNY College of Optometry Clinical Vision Research Center
    • North Carolina
      • Apex, North Carolina, United States, 27502
        • NC Eye Associates, OD, PLLC
      • Charlotte, North Carolina, United States, 28278
        • See Eye Care Optometry
    • Ohio
      • Granville, Ohio, United States, 43023
        • ProCare Vision Centers, Inc.
      • Powell, Ohio, United States, 43065
        • Eyecare Professionals, Inc
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Wyomissing Optometric Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • West Bay Eye Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Southern College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months;
  • Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D);
  • Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) in each eye.

Key Exclusion Criteria:

  • Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
  • History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye;
  • Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LID023681, then LID006961
Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
Device: Delefilcon A contact lenses with different base curves and diameters
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Other Names:
  • LID023681
Device: Delefilcon A contact lenses with standard base curves and diameters
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Other Names:
  • DAILIES TOTAL1®
  • LID006961
Other: LID006961, then LID023681
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
Device: Delefilcon A contact lenses with different base curves and diameters
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Other Names:
  • LID023681
Device: Delefilcon A contact lenses with standard base curves and diameters
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Other Names:
  • DAILIES TOTAL1®
  • LID006961

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Primary Gaze
Time Frame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Peripheral Gazes
Time Frame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at Dispense in Lens Position (Centration)
Time Frame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Primary Gaze
Time Frame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Peripheral Gazes
Time Frame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in Lens Position (Centration)
Time Frame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Principal Clinical Trial Lead, Vision Care, Alcon Research, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Actual)

August 26, 2025

Study Completion (Actual)

August 26, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLU484-P007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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