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Safety and Effectiveness of the Qualis Contact Lens

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
soft (hydrophilic) contact lens
Sponsored by
Unicon Optical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The subject must read, understand, and sign the informed consent form and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be at least 18 years of age. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. The subject's refractive cylinder must be ≤ 0.75 Diopters in each eye. The subject must have best corrected visual acuity of 20/25 (LogMAR) or better in each eye. Subjects should own a wearable pair of spectacles. The subject must have normal eyes (i.e., no ocular medications or infections of any type). Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week Exclusion Criteria: Subjects may not be enrolled into the study if ANY of the following apply: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). The use of systemic or ocular medications that would contraindicate contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.). Any grade 2 or greater slit lamp findings for corneal staining, and any grade 3 or greater slit lamp findings for other abnormalities (e.g., edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) on the ISO 11980 classification scale, any current inflammatory events or events within the last 6 months, or any other ocular abnormality that may contraindicate contact lens wear. Any known hypersensitivity or allergic reaction to Biotrue or ClearCare contact lens care solutions Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Extended wear, monovision or multi-focal contact lens correction. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. Any subject where the randomized lens demonstrates a fit that is deemed inappropriate by the investigator, including, but not limited to, the lens being too flat, too steep, have excessive or inadequate movement, and/or insufficient limbal coverage. Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)

Sites / Locations

  • Ala Moana Advanced Eye Clinic
  • SUNY College of Optometry
  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Device: Qualis Silicone Hydrogel Soft Contact Lens

Control Device: Acuvue Vita Monthly Contact Lens

Arm Description

Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA.

Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA.

Outcomes

Primary Outcome Measures

Number of Eyes With Non-Serious Adverse Reactions
The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.
Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better
The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better

Secondary Outcome Measures

Full Information

First Posted
March 2, 2020
Last Updated
October 17, 2023
Sponsor
Unicon Optical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04295499
Brief Title
Safety and Effectiveness of the Qualis Contact Lens
Official Title
Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens Over 3 Months of Daily Wear
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unicon Optical Co. Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.
Detailed Description
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study comparing the Qualis Silicone Hydrogel Soft Contact Lens for Daily Wear with the currently marketed Acuvue Vita (senofilcon C) Monthly Contact Lens (FDA cleared under K160212). Eligible subjects will be examined for baseline evaluation and lens fitting. Up to fifty (50) subjects will wear the test contact lenses and up to twenty-five (25) subjects will wear the control contact lenses. The subjects will undergo standard ophthalmic evaluation for contact lens wear and will be followed for a period of at least ninety (91) days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Device: Qualis Silicone Hydrogel Soft Contact Lens
Arm Type
Experimental
Arm Description
Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA.
Arm Title
Control Device: Acuvue Vita Monthly Contact Lens
Arm Type
Active Comparator
Arm Description
Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA.
Intervention Type
Device
Intervention Name(s)
soft (hydrophilic) contact lens
Intervention Description
The intervention is a daily wear soft contact lens
Primary Outcome Measure Information:
Title
Number of Eyes With Non-Serious Adverse Reactions
Description
The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.
Time Frame
91 days
Title
Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better
Description
The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better
Time Frame
91 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject must read, understand, and sign the informed consent form and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be at least 18 years of age. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. The subject's refractive cylinder must be ≤ 0.75 Diopters in each eye. The subject must have best corrected visual acuity of 20/25 (LogMAR) or better in each eye. Subjects should own a wearable pair of spectacles. The subject must have normal eyes (i.e., no ocular medications or infections of any type). Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week Exclusion Criteria: Subjects may not be enrolled into the study if ANY of the following apply: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). The use of systemic or ocular medications that would contraindicate contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.). Any grade 2 or greater slit lamp findings for corneal staining, and any grade 3 or greater slit lamp findings for other abnormalities (e.g., edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) on the ISO 11980 classification scale, any current inflammatory events or events within the last 6 months, or any other ocular abnormality that may contraindicate contact lens wear. Any known hypersensitivity or allergic reaction to Biotrue or ClearCare contact lens care solutions Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Extended wear, monovision or multi-focal contact lens correction. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. Any subject where the randomized lens demonstrates a fit that is deemed inappropriate by the investigator, including, but not limited to, the lens being too flat, too steep, have excessive or inadequate movement, and/or insufficient limbal coverage. Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)
Facility Information:
Facility Name
Ala Moana Advanced Eye Clinic
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
SUNY College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Effectiveness of the Qualis Contact Lens

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