Refractive ErrorsNCT04295499
Safety and Effectiveness of the Qualis Contact Lens
A study testing soft (hydrophilic) contact lens in people with Refractive Errors, run by Unicon Optical Co. Ltd. at 3 sites in United States.
Trial summary
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- soft (hydrophilic) contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2020to 28 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.).
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- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ohio State University
Columbus, Ohio, 43210
Ala Moana Advanced Eye Clinic
Honolulu, Hawaii, 96814
SUNY College of Optometry
New York, New York, 10036
About this study
Official title: Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens Over 3 Months of Daily Wear
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.
Read the 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.
- Conditions
- Refractive Errors
- Being tested
- soft (hydrophilic) contact lens
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft (hydrophilic) contact lensDevice
The intervention is a daily wear soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Experimental | 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. Receives: Device: soft (hydrophilic) contact lens |
| Control Device: Acuvue Vita Monthly Contact Lens | Active comparator | 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. Receives: Device: soft (hydrophilic) contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 91 days
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
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Jul 2020
- Primary completion28 Jan 2021
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unicon Optical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295499
- Sponsor's protocol ID
- US-PRO1904001
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2020
- Last updated
- 19 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens Over 3 Months of Daily Wear
- ClinicalTrials.gov ID
- NCT04295499
- Acronym / sponsor ID
- US-PRO1904001
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Unicon Optical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 8 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Experimental | Device: soft (hydrophilic) contact lensTest 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. |
| Control Device: Acuvue Vita Monthly Contact Lens | Active comparator | Device: soft (hydrophilic) contact lensTest 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soft (hydrophilic) contact lensThe intervention is a daily wear soft contact lens | Device | Control Device: Acuvue Vita Monthly Contact Lens, Test Device: Qualis Silicone Hydrogel Soft Contact Lens |
Primary outcome
Number of Eyes With Non-Serious Adverse Reactions
Time frame: 91 days
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
Time frame: 91 days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft (hydrophilic) contact lens in people with Refractive Errors, run by Unicon Optical Co. Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Eyes With Non-Serious Adverse Reactions (time frame: 91 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.