Evaluation of Delefilcon A Contact Lenses

NCT06884202 | Completed FDA Device

• 1 other identifier: CLU484-P007
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Refractive Errors; Myopia

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

LID023681, then LID006961

OTHER

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; Device: Delefilcon A contact lenses with standard base curves and diameters

LID006961, then LID023681

OTHER

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; Device: Delefilcon A contact lenses with standard base curves and diameters

Interventions

Delefilcon A contact lenses with different base curves and diameters DEVICE

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.

Also known as: LID023681

LID006961, then LID023681; LID023681, then LID006961

Delefilcon A contact lenses with standard base curves and diameters DEVICE

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.

Also known as: DAILIES TOTAL1®, LID006961

LID006961, then LID023681; LID023681, then LID006961

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (16)

Kurata Eyecare Center

Los Angeles, California, 90013, United States

Location

Elsa Pao, OD

Oakland, California, 94607, United States

Location

Pacific Rims Optometry

San Francisco, California, 94127, United States

Location

Pearson Research Center, PA

Longwood, Florida, 32779, United States

Location

Kindred Optics at Maitland Vision

Maitland, Florida, 32751, United States

Location

Eyeconic Family Eyecare

Dallas, Georgia, 30157, United States

Location

Dr. Schwartz Optometrist and Associates

Sterling Heights, Michigan, 48312, United States

Location

Coldwater Vision Research

Coldwater, Mississippi, 38618, United States

Location

SUNY College of Optometry Clinical Vision Research Center

New York, New York, 10036, United States

Location

NC Eye Associates, OD, PLLC

Apex, North Carolina, 27502, United States

Location

See Eye Care Optometry

Charlotte, North Carolina, 28278, United States

Location

ProCare Vision Centers, Inc.

Granville, Ohio, 43023, United States

Location

Eyecare Professionals, Inc

Powell, Ohio, 43065, United States

Location

Wyomissing Optometric Center

Wyomissing, Pennsylvania, 19610, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Principal Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

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: March 13, 2025
• First Posted: March 19, 2025
• Study Start: April 28, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)