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

April 12, 2019 updated by: Clerio Vision, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14607
        • Clerio Vision Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Device
Within this arm the Clerio Vision LIRIC-modified Bifocal Contact Lens is administered.
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.
Other Names:
  • Clerio Vision Bifocal Contact Lens
  • Clerio Vision Multifocal Contact Lens
  • Laser-Induced Refractive Index Change (LIRIC) Bifocal Contact Lens
Active Comparator: Control Devices
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
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.
Other Names:
  • Commercially Available Multifocal Contact Lens
  • Control Multifocal Contact Lens
  • Etafilcon A
Device: 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.
Other Names:
  • Etafilcon A
  • Commercially Available Single Vision Contact Lens
  • Control Single Vision Contact Lens
Device: 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.
Other Names:
  • Control Single Vision Contact Lens
  • Contamac 49 Single Vision Contact Lens
  • Acofilcon B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clerio Vision, Inc.

Investigators

  • Principal Investigator: Michele Lagana, OD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

August 27, 2018

Study Completion (Actual)

October 12, 2018

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVR-18-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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