Evaluating Contact Lens Optics

• Single vision contact lens (Device), also known as comfilcon A: Participants will wear a single vision soft contact lens during the study visit
• Multifocal contact lens (Device), also known as comfilcon A: Participants will wear a multifocal soft contact lens during the study visit

Primary outcomes

• Visual Performance [Through completion of study visit, an average of 2.5 hours]: Low contrast visual acuity was measured for each participant while wearing each of the two lenses

Secondary outcomes

• Spherical Equivalent Refractive Error On-axis [Through completion of study visit, an average of 2.5 hours]: Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged.
• Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina [Through completion of study visit, an average of 2.5 hours]: Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
• Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina [Through completion of study visit, an average of 2.5 hours]: Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
• Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina [Through completion of study visit, an average of 2.5 hours]: Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
• Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina [Through completion of study visit, an average of 2.5 hours]: Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.

Sex: All, ages: 18 Years to 39 Years

Inclusion Criteria:

* Able to read and understand the informed consent document
* 18 to 39 years of age (inclusive)
* Best corrected visual acuity of 20/25 or better in the right eye
* Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

Exclusion Criteria:

* Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
* History of ocular trauma or surgery causing abnormal or distorted vision
* Current Rigid Gas Permeable (RGP) contact lens wearers
* Unwilling to have contact lens fit photographed
* Pregnant and/or lactating females, by self-report

Participant flow

Outcome results

• Visual Performance (Primary), Mean, logMAR: Single Vision Contact Lens 0.23 +/- 0.08; Multifocal Contact Lens 0.38 +/- 0.12
• Spherical Equivalent Refractive Error On-axis (Secondary), Mean, D: Single Vision Soft Contact Lens 0.61 +/- 0.46; Multifocal Soft Contact Lens 0.17 +/- 0.44
• Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina (Secondary), Mean, D: Single Vision Contact Lens 0.68 +/- 1.03; Multifocal Contact Lens -1.20 +/- 1
• Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina (Secondary), Mean, D: Single Vision Contact Lens 0.52 +/- 0.68; Multifocal Contact Lens -1.30 +/- 0.44
• Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina (Secondary), Mean, D: Single Vision Contact Lens 0.67 +/- 0.58; Multifocal Contact Lens -0.17 +/- 0.57
• Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina (Secondary), Mean, D: Single Vision Contact Lens 0.77 +/- 0.70; Multifocal Contact Lens -0.75 +/- 0.60

Adverse events

Time frame: 2.5 hours

• Study Protocol and Statistical Analysis Plan (PDF, 2020-10-16)
• Informed Consent Form (PDF, 2020-10-16)

• David A Berntsen, OD, PhD, Principal investigator, University of Houston College of Optometry