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Completed

NCT Number: NCT06884202

Evaluation of Delefilcon A Contact Lenses

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

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Key information

Conditions

Refractive Errors Eye Diseases Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kurata Eyecare Center, Los Angeles, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: LID023681

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.

Other names: DAILIES TOTAL1®, LID006961

Primary outcomes

  1. 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 (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).

  2. 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 (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).

  3. 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 (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.

  4. 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 (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).

  5. 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 (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).

  6. 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 (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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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