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

Presbyopia Clinical Trial

Official title:

Clinical Performance Study of Clerio Single Vision and Bifocal Contact Lens Designs Immediately Following Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653715
• Other study ID #: CVR-18-001
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: October 12, 2018

Study information

• Verified date: April 2019
• Source: Clerio Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 12, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

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

Locations

Country	Name	City	State
United States	Clerio Vision Research Clinic	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Clerio Vision, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Ding L, Knox WH, Bühren 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Secondary	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	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.	starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Secondary	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	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.	starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)