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

NCT03653715 | Completed FDA Device

• 1 other identifier: CVR-18-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Keywords

Refractive Errors; Myopia; Hyperopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Test Device

EXPERIMENTAL

Within this arm the Clerio Vision LIRIC-modified Bifocal Contact Lens is administered.

Device: Clerio Vision LIRIC-modified Bifocal Contact Lens

Control Devices

ACTIVE COMPARATOR

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.

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

Interventions

Clerio Vision LIRIC-modified Bifocal Contact Lens DEVICE

Within this arm the investigational acofilcon B material bifocal contact lens, which has been modified with the laser and is the focus of the study, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Also known as: Clerio Vision Bifocal Contact Lens, Clerio Vision Multifocal Contact Lens, Laser-Induced Refractive Index Change (LIRIC) Bifocal Contact Lens

Test Device

Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens DEVICE

Within this arm the control etafilcon A material bifocal contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Also known as: Commercially Available Multifocal Contact Lens, Control Multifocal Contact Lens, Etafilcon A

Control Devices

Johnson & Johnson 1-Day Acuvue Moist Contact Lens DEVICE

Within this arm the control etafilcon A material single vision contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Also known as: Commercially Available Single Vision Contact Lens, Control Single Vision Contact Lens, Etafilcon A

Control Devices

Clerio Vision Single Vision Contact Lens DEVICE

Within this arm the control acofilcon B material single vision contact lens, the material of which is commercially available from Contamac Ltd, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Also known as: Contamac 49 Single Vision Contact Lens, Control Single Vision Contact Lens, Acofilcon B

Control Devices

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clerio Vision, Inc.: lead

Study Sites (1)

Clerio Vision Research Clinic

Rochester, New York, 14607, United States

Location

Related Publications (5)

• 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.

  PMID: 19529613 BACKGROUND

• 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.

  PMID: 18641284 BACKGROUND

• 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.

  PMID: 21931133 BACKGROUND

• 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.

  PMID: 24985471 BACKGROUND

• 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.

  PMID: 28866013 BACKGROUND

MeSH Terms

Conditions

Presbyopia; Refractive Errors; Myopia; Hyperopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Michele Lagana, OD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The Principal Investigator and Clinical Research Technicians, because they handle the contact lenses both in and out of their packaging, are not masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 31, 2018
• Study Start: August 6, 2018
• Primary Completion: August 27, 2018
• Study Completion: October 12, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)