Evaluation of Delefilcon A Contact Lenses

Not Applicable

Recruiting

• Conditions: Refractive Errors; Myopia

• Registration Number: NCT06884202
• Lead Sponsor: Alcon Research

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-19
• Status Verified: 2025-04
• Study Start: 2025-04-28
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at Dispense in lens position (centration)	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.
Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in lens position (centration)	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.
Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at primary gaze	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).
Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at peripheral gazes	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).
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	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).
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	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).

Trial Locations

Locations (12)

Kurata Eyecare Center; 🇺🇸 Los Angeles, California, United States

Elsa Pao, OD; 🇺🇸 Oakland, California, United States

Pacific Rims Optometry; 🇺🇸 San Francisco, California, United States

Pearson Research Center, PA; 🇺🇸 Longwood, Florida, United States

Kindred Optics at Maitland Vision; 🇺🇸 Maitland, Florida, United States

Eyeconic Family Eyecare; 🇺🇸 Dallas, Georgia, United States

SUNY College of Optometry Clinical Vision Research Center; 🇺🇸 New York, New York, United States

NC Eye Associates, OD, PLLC; 🇺🇸 Apex, North Carolina, United States

See Eye Care Optometry; 🇺🇸 Charlotte, North Carolina, United States

ProCare Vision Centers, Inc.; 🇺🇸 Granville, Ohio, United States

Eyecare Professionals, Inc; 🇺🇸 Powell, Ohio, United States

West Bay Eye Associates; 🇺🇸 Warwick, Rhode Island, United States