Evaluation of Delefilcon A Contact Lenses

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: Refractive Errors; Myopia
• Intervention / Treatment: Device: Delefilcon A contact lenses with different base curves and diameters; Device: Delefilcon A contact lenses with standard base curves and diameters

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): 257
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens movement (overall lens fit) will be 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).	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	Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in upward gaze, downward gaze, looking to the left, and looking to the right. Lens movement (overall lens fit) for each gaze will be 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).	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)	Lens position (centration) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens position (centration) will be graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable centration; 2 = Unacceptable decentration.	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	Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens movement (overall lens fit) will be 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).	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	Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in upward gaze, downward gaze, looking to the left, and looking to the right. Lens movement (overall lens fit) for each gaze will be 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).	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)	Lens position (centration) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens position (centration) will be graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable centration; 2 = Unacceptable decentration.	Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period

Collaborators and Investigators

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

Study record dates

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 (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• 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