Clinical trial NCT03653715: Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss
Official title: Clinical Performance Study of Clerio Single Vision and Bifocal Contact Lens Designs Immediately Following Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Refractive Errors
Myopia
Hyperopia
Astigmatism
Lead sponsor: Clerio Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This single center study is a device feasibility, two-arm, double-masked (participants and outcomes assessor), repeated measures, cross-sectional design. Each participant is tested with the four (4) study devices (i.e., contact lenses), one (1) test lens and three (3) control lenses, in randomized order. Participants are masked to each lens they wear.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Secondary outcomes:
measure: 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
timeFrame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
measure: 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
timeFrame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
measure: 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
timeFrame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Clerio Vision Research Clinic
state: New York
Study officials:
name: Michele Lagana, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ding L, Blackwell R, Kunzler JF, Knox WH. Large refractive index change in silicone-based and non-silicone-based hydrogel polymers induced by femtosecond laser micro-machining. Opt Express. 2006 Nov 27;14(24):11901-9. doi: 10.1364/oe.14.011901.
citation: Ding L, Knox WH, Buhren J, Nagy LJ, Huxlin KR. Intratissue refractive index shaping (IRIS) of the cornea and lens using a low-pulse-energy femtosecond laser oscillator. Invest Ophthalmol Vis Sci. 2008 Dec;49(12):5332-9. doi: 10.1167/iovs.08-1921. Epub 2008 Jul 18.
citation: Xu L, Knox WH, DeMagistris M, Wang N, Huxlin KR. Noninvasive intratissue refractive index shaping (IRIS) of the cornea with blue femtosecond laser light. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8148-55. doi: 10.1167/iovs.11-7323.
citation: Savage DE, Brooks DR, DeMagistris M, Xu L, MacRae S, Ellis JD, Knox WH, Huxlin KR. First demonstration of ocular refractive change using blue-IRIS in live cats. Invest Ophthalmol Vis Sci. 2014 Jul 1;55(7):4603-12. doi: 10.1167/iovs.14-14373.
citation: Wozniak KT, Elkins N, Brooks DR, Savage DE, MacRae S, Ellis JD, Knox WH, Huxlin KR. Contrasting cellular damage after Blue-IRIS and Femto-LASIK in cat cornea. Exp Eye Res. 2017 Dec;165:20-28. doi: 10.1016/j.exer.2017.08.018. Epub 2017 Aug 31.