Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss

Not Applicable

Completed

Conditions: Presbyopia

Interventions: Device: Clerio Vision LIRIC-modified Bifocal Contact Lens
Device: Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens
Device: Johnson & Johnson 1-Day Acuvue Moist Contact Lens
Device: Clerio Vision Single Vision Contact Lens

Registration Number: NCT03653715

Lead Sponsor: Clerio Vision, Inc.

Brief Summary: The primary objective of this study is to evaluate the distance, intermediate and near visual performance of Clerio designed single vision and Clerio designed LIRIC modified bifocal lenses (+2.00D add) compared to commercially available single vision and multifocal lenses.

Detailed Description: Clerio Vision Inc. has licensed a new femtosecond based laser procedure discovered by researchers at the University of Rochester known as Laser Induced Refractive Index Customization (LIRIC), which allows the alteration of the optical design of a finished soft hydrogel contact lens. Clerio Vision Inc. scientists have developed a diffractive multifocal optical design using the LIRIC procedure which shows an increase of the depth of focus of the contact lens when measured on an optical bench. It is hypothesized that a presbyopic patient wearing a soft contact lens of this design will experience an improvement in intermediate and near vision over that provided by their distance corrected single vision contact lenses, without significantly impacting their distance vision. The purpose of this feasibility study is the on-eye evaluation of the performance of the Clerio Vision designed and LIRIC modified soft contact lenses. Results from this study will guide future development of these potential products.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Legal age (at least 21) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
Willing and able to comply with all study instructions/procedures.
Best Distance Spherical Corrected Visual Acuity (BDSCVA) in at least one eye of 20/25 (0.10 logMAR).
Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Previous experience with contact lenses.
Distance spectacle spherical correction in at least one eye within +/- 5D of the study lens power (-3.00D).
Habitual spectacle addition (at 40cm) of at least +1.00D.
Refractive astigmatism less than -2.75D.
Most recent complete eye examination was within the last 24 months of the date of study completion.

Exclusion Criteria

Currently participating in any drug or device clinical investigation during the period of study participation.
Active anterior segment ocular disease or using any ocular medication for anterior segment disease (e.g. conjunctivitis, dry-eye disease).
Current or past condition that might have caused corneal distortion or anterior surface topography abnormalities (e.g. keratoconus, map-dot fingerprint or any other corneal dystrophies, corneal disease or trauma resulting in scarring, pterygium, pellucid marginal degeneration)
Previous refractive corneal surgery (e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), corneal transplant, Descemet's Stripping Endothelial Keratoplasty (DSEK) etc.).
Considered by the Investigator to not be a suitable candidate for participation.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Devices	Johnson & Johnson 1-Day Acuvue Moist Contact Lens	Within this arm the Johnson \& Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson \& Johnson 1-Day Acuvue Moist Contact Lens, and Clerio Vision Single Vision Contact Lens are administered.
Control Devices	Clerio Vision Single Vision Contact Lens	Within this arm the Johnson \& Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson \& Johnson 1-Day Acuvue Moist Contact Lens, and Clerio Vision Single Vision Contact Lens are administered.
Test Device	Clerio Vision LIRIC-modified Bifocal Contact Lens	Within this arm the Clerio Vision LIRIC-modified Bifocal Contact Lens is administered.
Control Devices	Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens	Within this arm the Johnson \& Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson \& Johnson 1-Day Acuvue Moist Contact Lens, and Clerio Vision Single Vision Contact Lens are administered.

Primary Outcome Measures

Name	Time	Method
Comparison of Through-Focus High Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2	starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)	Visual acuity is measured under high contrast conditions (85% contrast relative to the chart background) at object testing distances of 5.3m, 2m, 1m, 67cm, 50cm and 40cm ("through-focus"), recorded in units of logMAR.

Secondary Outcome Measures

Name	Time	Method
Comparison of Visual Quality for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2	starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)	Visual quality is a subjective rating that a participant chooses using an analog rating chart ranging from 0 to 100. Participants are asked to look at the letters that they can read, not the ones that they can't, and rate how sharp those letters are, with 0 denoting "unacceptable" and 100 denoting "excellent." They are asked to reduce their score if any halos, glare, or double vision are present.
Comparison of Fitting Performance for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2	starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)	Fitting performance is measured by visual observation of the contact lens on a participant's eye using a slit lamp biomicroscope and ocular measurement reticle. The position of the lens edge relative to the corneal boundaries both immediately before and immediately after a blink is measured.
Comparison of Through-Focus Low Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2	starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)	Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 5.3m, 2m, 1m, 67cm, 50cm and 40cm ("through-focus"), recorded in units of logMAR.