Clinical trial NCT06884202: Evaluation of Delefilcon A Contact Lenses
Official title: Clinical Evaluation of Overall Lens Fit of Delefilcon A Contact Lenses of Different Diameters and Base Curves
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractive Errors
Myopia
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at primary gaze
timeFrame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
measure: Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at peripheral gazes
timeFrame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
measure: Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at Dispense in lens position (centration)
timeFrame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
measure: 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
timeFrame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
measure: 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
timeFrame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
measure: Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in lens position (centration)
timeFrame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kurata Eyecare Center
state: California
city: Oakland
country: United States
facility: Elsa Pao, OD
state: California
city: San Francisco
country: United States
facility: Pacific Rims Optometry
state: California
city: Longwood
country: United States
facility: Pearson Research Center, PA
state: Florida
city: Maitland
country: United States
facility: Kindred Optics at Maitland Vision
state: Florida
city: Dallas
country: United States
facility: Eyeconic Family Eyecare
state: Georgia
city: New York
country: United States
facility: SUNY College of Optometry Clinical Vision Research Center
state: New York
city: Apex
country: United States
facility: NC Eye Associates, OD, PLLC
state: North Carolina
city: Charlotte
country: United States
facility: See Eye Care Optometry
state: North Carolina
city: Granville
country: United States
facility: ProCare Vision Centers, Inc.
state: Ohio
city: Powell
country: United States
facility: Eyecare Professionals, Inc
state: Ohio
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
Study officials:
affiliation: Alcon Research, LLC
name: Principal Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: