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Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens

Primary Purpose

Refractive Error - Myopia Bilateral

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deseyne Daily Disposable Contact Lens (Test Device)
Sponsored by
Bruno Vision Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Refractive Error - Myopia Bilateral

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 to 40 years of age on the date the informed consent form (ICF) is signed Presence of clear central corneas and absence of any anterior segment disorders in each eye Presence of myopia and requirement for lens correction from -1.00 D to -6.00 D in each eye Best-corrected distance visual acuity (BCDVA) of 50 ETDRS letters (0.1 logMAR) or better in each eye Be an adapted soft contact lens wearer in each eye and agree to wear study lenses in each eye on a daily wear basis and not wear a non-study lens for approximately 3 months Able and willing to comply with all treatment and follow-up/study procedures Able to read, understand, and provide written informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations Exclusion Criteria: Participation in any drug or device clinical investigation within 2 weeks prior to Screening and/or during the period of study participation Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who meet any of the following conditions: Currently pregnant Plans to become pregnant during the study Currently breastfeeding History of gas permeable lens wear in either eye within 30 days prior to Screening or history of polymethylmethacrylate lens wear in either eye within 3 months prior to Screening Current monovision, multifocal, or toric contact lens wear in either eye In either eye, current nonabsorbable punctal plug or implantation of absorbable punctal plug within 2 to 6 months (depending on type of absorbable plug) prior to Screening, or punctal plug removal within 2 months prior to Screening. Permanent punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye is excluded Use of any prescription ocular medication throughout the duration of the study. Prescription eyedrops for dry eye disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as well as nasally administered Tyrvaya, must be discontinued 2 weeks prior to Screening and are prohibited throughout the duration of the study Clinical Study Protocol Version 3.0, 26 April 2023 Page 17 of 66 Bruno Vision Care Protocol 22001 Use of over-the-counter eyedrops (eg, oxymetazoline, naphazoline, ketotifen, etc.), except for unpreserved lubricant eyedrops or artificial tears (eg, Systane, Refresh), within 1 week prior to Screening and throughout the duration of the study Use of any systemic or topical medications that may, in the Investigator's opinion, affect ocular physiology or lens performance Anisometropia (spherical equivalent) >2.00 D Ocular astigmatism >1.00 D in either eye Amblyopia in either eye Aphakia in either eye Active ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, keratitis, etc.) in either eye. Subjects must be symptom free for at least 7 days History or evidence of ocular infection within 30 days prior to Screening History or evidence of ocular herpes simplex or ocular herpes zoster Any grade corneal infiltrates in either eye Grade ≥2 finding in either eye during slit lamp examination Any "Present" finding in either eye during slit lamp examination that, in the Investigator's opinion, may interfere with contact lens wear Any scar or neovascularization within the central 4 mm of the cornea in either eye. Subjects with minor peripheral corneal scarring (not extending into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible to participate in this study History of any corneal surgery (eg, refractive surgery or therapeutic) in either eye Any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study Allergy to any component in the study care products Meet any of the following criteria: Subject is an employee of the investigative site Subject or a member of the subject's household is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician Subject or a member of the subject's household is an employee of a manufacturer of contact lenses or contact lens care products Subject or a member of the subject's household is an employee of a market research firm -

Sites / Locations

  • Christopher Pearson, O.D.
  • Shane R Kannarr, OD
  • Athens Eye Care
  • Stephen Montaquila, O.D.
  • David G Evans, OD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test lens. Deseyne Daily Disposable Contact Lens

Control lens. 1-Day Acuvue Moist Daily Disposable Contact Lens

Arm Description

Test contact lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily. Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing.

Control lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily, Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing.

Outcomes

Primary Outcome Measures

Primary Effectiveness Outcome Measure
logMAR Visual Acuity, Each eye, change from baseline at each follow up visit

Secondary Outcome Measures

Secondary Effectiveness Outcome
Lens deposits [Type, percent, corneal location, degree.] Change from baseline at each follow up visit.
Wettability
Analog Scale 0-4 (0=100% wettable, 4=more than one dry spot greater than 0.5mm
Lens Movement
Analog scale 0-4 (0= adequate, 4= adherence to cornea)
Lens Centration
Analog scale 0-4 (0=superior cornea, 4= inferior cornea)

Full Information

First Posted
May 31, 2023
Last Updated
July 19, 2023
Sponsor
Bruno Vision Care
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1. Study Identification

Unique Protocol Identification Number
NCT05927753
Brief Title
Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens
Official Title
A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bruno Vision Care

4. Oversight

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
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical study is to provide clinical performance data comparing the test lens (Deseyne [vifilcon C] daily disposable soft contact lens) to a control lens (1-Day Acuvue Moist [etafilcon A] daily disposable soft contact lens) in the same indication for use (single use prior to removal followed by a fresh lens upon the next lens wear exposure). The study is designed to test the hypothesis that the test lens is substantially equivalent to the control lens in like indications for use.
Detailed Description
A multicenter, randomized, active-controlled, open-label study design will be used to compare the clinical performance of the Deseyne (vifilcon C) test soft contact lens to the similarly indicated 1-Day Acuvue® Moist® (etafilcon A) control soft contact lens. Study participation is approximately 90 days in duration and will consist of approximately 80 subjects assigned in a 2:1 ratio to test or control lens bilaterally, respectively. Subjects must be otherwise healthy, with myopia between -1.00 D and -6.00 D and astigmatism no greater than 1.00 D that does not interfere with VA. At the Screening Visit, approximately two-thirds of the eligible subjects will be randomized to receive the test lens (Deseyne [vifilcon C] lenses) and the other one-third eligible subjects will be randomized to receive the control lens (1-Day Acuvue Moist [etafilcon A] lenses). At the Dispensing Visit (Visit 2), subjects will be provided with test or control lenses as part of the dispensing package, along with instructions for the use and care of the lenses. They will be recommended unpreserved lubricating/rewetting solution for use as needed during the study. Subjects will wear their assigned lenses bilaterally on a daily wear basis, for a minimum of 6 hours/day throughout the study (no maximum time is mandated, as long as subjects do not sleep in their lenses), with additional visits planned for 1 Week (Visit 3), 1 Month (Visit 4), 2 Months (Visit 5), and 3 Months/Exit Visit (Visit 6). This study follows United States Food and Drug Administration (FDA) Premarket Notification 510(k) Guidance for Daily Wear Contact Lenses adopted in May 1994, and any unpublished subsequent policy declarations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error - Myopia Bilateral

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of a test contact lens performance to a known, cleared for market contact lens.
Masking
None (Open Label)
Masking Description
Open label randomization assignment between test and control intervention.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test lens. Deseyne Daily Disposable Contact Lens
Arm Type
Experimental
Arm Description
Test contact lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily. Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing.
Arm Title
Control lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
Arm Type
Active Comparator
Arm Description
Control lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily, Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing.
Intervention Type
Device
Intervention Name(s)
Deseyne Daily Disposable Contact Lens (Test Device)
Intervention Description
Comparison of contact lens performance between the test lens under study (Deseyne Daily Disposable Contact Lens) and the control lens f(1-Day Acuvue Moist Contact Lens) for safety and effectiveness.
Primary Outcome Measure Information:
Title
Primary Effectiveness Outcome Measure
Description
logMAR Visual Acuity, Each eye, change from baseline at each follow up visit
Time Frame
Baseline, 1 mo., 2 mo., 3 mo.
Secondary Outcome Measure Information:
Title
Secondary Effectiveness Outcome
Description
Lens deposits [Type, percent, corneal location, degree.] Change from baseline at each follow up visit.
Time Frame
Follow up visits 1 mo., 2 mo., 3 mo.
Title
Wettability
Description
Analog Scale 0-4 (0=100% wettable, 4=more than one dry spot greater than 0.5mm
Time Frame
Initial and each follow up visit 1 mo, 2 mo, 3 mo.
Title
Lens Movement
Description
Analog scale 0-4 (0= adequate, 4= adherence to cornea)
Time Frame
Initial and each follow up visit 1 mo., 2 mo., 3 mo.
Title
Lens Centration
Description
Analog scale 0-4 (0=superior cornea, 4= inferior cornea)
Time Frame
Initial and each follow up visit 1 mo, 2 mo, 3mo.
Other Pre-specified Outcome Measures:
Title
Primary Safety Outcome Measure
Description
Quantative and qualitative slit lamp findings including corneal edema [epithelial, stromal], corneal infiltrates, corneal vascularization, corneal staining, palpebral conjunctival injection, conjunctival hyperemia, and limbal injection. Standardized Analog scale 0-4 with 0=no finding, and 4 being Severe finding.
Time Frame
At any time during the study and up to final visit at 3 months (90 days.)
Title
Secondary Safety Outcome Measures
Description
Adverse reactions (serious and incidental), adverse device effects, pinhole VA [for eyes with a 2-line decrease in BCVA logMAR or worse from baseline]
Time Frame
At any time during the study and up to final visit at 3 mo (90 days.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 to 40 years of age on the date the informed consent form (ICF) is signed Presence of clear central corneas and absence of any anterior segment disorders in each eye Presence of myopia and requirement for lens correction from -1.00 D to -6.00 D in each eye Best-corrected distance visual acuity (BCDVA) of 50 ETDRS letters (0.1 logMAR) or better in each eye Be an adapted soft contact lens wearer in each eye and agree to wear study lenses in each eye on a daily wear basis and not wear a non-study lens for approximately 3 months Able and willing to comply with all treatment and follow-up/study procedures Able to read, understand, and provide written informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations Exclusion Criteria: Participation in any drug or device clinical investigation within 2 weeks prior to Screening and/or during the period of study participation Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who meet any of the following conditions: Currently pregnant Plans to become pregnant during the study Currently breastfeeding History of gas permeable lens wear in either eye within 30 days prior to Screening or history of polymethylmethacrylate lens wear in either eye within 3 months prior to Screening Current monovision, multifocal, or toric contact lens wear in either eye In either eye, current nonabsorbable punctal plug or implantation of absorbable punctal plug within 2 to 6 months (depending on type of absorbable plug) prior to Screening, or punctal plug removal within 2 months prior to Screening. Permanent punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye is excluded Use of any prescription ocular medication throughout the duration of the study. Prescription eyedrops for dry eye disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as well as nasally administered Tyrvaya, must be discontinued 2 weeks prior to Screening and are prohibited throughout the duration of the study Clinical Study Protocol Version 3.0, 26 April 2023 Page 17 of 66 Bruno Vision Care Protocol 22001 Use of over-the-counter eyedrops (eg, oxymetazoline, naphazoline, ketotifen, etc.), except for unpreserved lubricant eyedrops or artificial tears (eg, Systane, Refresh), within 1 week prior to Screening and throughout the duration of the study Use of any systemic or topical medications that may, in the Investigator's opinion, affect ocular physiology or lens performance Anisometropia (spherical equivalent) >2.00 D Ocular astigmatism >1.00 D in either eye Amblyopia in either eye Aphakia in either eye Active ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, keratitis, etc.) in either eye. Subjects must be symptom free for at least 7 days History or evidence of ocular infection within 30 days prior to Screening History or evidence of ocular herpes simplex or ocular herpes zoster Any grade corneal infiltrates in either eye Grade ≥2 finding in either eye during slit lamp examination Any "Present" finding in either eye during slit lamp examination that, in the Investigator's opinion, may interfere with contact lens wear Any scar or neovascularization within the central 4 mm of the cornea in either eye. Subjects with minor peripheral corneal scarring (not extending into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible to participate in this study History of any corneal surgery (eg, refractive surgery or therapeutic) in either eye Any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study Allergy to any component in the study care products Meet any of the following criteria: Subject is an employee of the investigative site Subject or a member of the subject's household is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician Subject or a member of the subject's household is an employee of a manufacturer of contact lenses or contact lens care products Subject or a member of the subject's household is an employee of a market research firm -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Slonim, MD
Organizational Affiliation
iuvobioscience
Official's Role
Study Director
Facility Information:
Facility Name
Christopher Pearson, O.D.
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Shane R Kannarr, OD
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Athens Eye Care
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Stephen Montaquila, O.D.
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
David G Evans, OD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens

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