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

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ClinicalTrials.gov Identifier: NCT03653715
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Presbyopia 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The Principal Investigator and Clinical Research Technicians, because they handle the contact lenses both in and out of their packaging, are not masked.
Primary Purpose: Treatment
Official Title: Clinical Performance Study of Clerio Single Vision and Bifocal Contact Lens Designs Immediately Following Insertion
Actual Study Start Date : August 6, 2018
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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:
  • Commercially Available Single Vision Contact Lens
  • Control Single Vision Contact Lens
  • Etafilcon A

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:
  • Contamac 49 Single Vision Contact Lens
  • Control Single Vision Contact Lens
  • Acofilcon B




Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. 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.

  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.

  3. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653715


Locations
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United States, New York
Clerio Vision Research Clinic
Rochester, New York, United States, 14607
Sponsors and Collaborators
Clerio Vision, Inc.
Investigators
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Principal Investigator: Michele Lagana, OD

Publications:
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Responsible Party: Clerio Vision, Inc.
ClinicalTrials.gov Identifier: NCT03653715     History of Changes
Other Study ID Numbers: CVR-18-001
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Clerio Vision, Inc.:
Refractive Errors
Myopia
Hyperopia
Astigmatism
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases