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MyopiaNCT04226560

Performance and Safety of Silicone Hydrogel Soft Contact Lenses

A study testing 41% Silicone Hydrogel Soft Contact Lenses(SHSCL), ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens and Contact Lens Care Product in people with Myopia, run by ApexLens Co., Ltd. at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Myopia
What is being tested?
41% Silicone Hydrogel Soft Contact Lenses(SHSCL), ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens and Contact Lens Care Product
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteTaiwan
Study dates
20 Apr 2020to 30 May 2021
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A person is eligible for inclusion in the study if he/she:
  • Healthy adult males or females age ≥20-45 years of age;
  • Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment) and the last contact lenses worn more than a week ago;
  • Have a contact lens powers between -2.00D and -6.00D (both inclusive) in both eyes;
  • Astigmatism of 1.00D or less in both eyes;
  • Be able to wear the lens powers available for this study;
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  • Be correctable to a visual acuity of 0.8 decimal (+0.10 logMAR) or better in each eye;
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
  • The subject must read and sign the Informed Consent form.

Who cannot join

  • A person will be excluded from the study if he/she:
  • Previously unsuccessful with contact lens wear, worn rigid gas permeable contact lenses within past 12 months;
  • Women who are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  • Any ocular or systemic allergies or diseases that may contraindicate contact lens wear;
  • Any ocular medications use within the last one month;
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear;
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  • Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report;
  • Any current or previous orthokeratology treatment, or planned for orthokeratology treatment during the study;
  • Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or planned for ocular and/or refractive surgery during the study
  • History of herpetic keratitis;
  • History of binocular vision abnormality or strabismus, by self-report;
  • Allergic reactions to test lens, control lens or the contact lens solution used in this study;
  • A clinical finding or history of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report;
  • Employee of investigational clinic (e.g., Investigator, Coordinator, Technician);
  • Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment;
  • Any slit lamp findings which would contraindicate contact lens wear;
  • Any history of a contact lens-related corneal inflammatory event within the past 12 months that may contraindicate contact lens wear; or
  • Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures;
  • Subjects are considered ineligible for the study as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

Rex Tsou contact

886-3-5752910 ext. 206

rex.tsou@apexlens.com

Taiwan1 site, 1 recruiting

  • ApexLens Co., Ltd.

    Hsinchu, 300

    Rex Tsou, 886-3-5752910 ext. 206, rex.tsou@apexlens.com

    Yih-Shiou Hwang, M.D.,Ph.D.

    Recruiting

Other trials in Taiwan

About this study

Official title: Clinical Evaluation of the Clinical Performance and Safety of a New Monthly Disposable Silicone Hydrogel Soft Contact Lenses

To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens

Read the detailed description

This study is a prospective, subject-masked, bilateral, randomized, parallel group dispensing study comparing the SHSCL test lens against the 1-Month ACUVUE® VITA™ (1-MAV) control lenses. Each subject will be randomized to wear either the test or of the control with similar/comparable lens parameters optimized for vision.

Both test and control lens will be used in their daily wear, monthly replacement modality for thirteen (13) weeks. It is anticipated that this study will involve up to 6 scheduled visits.

Conditions
Myopia
Being tested
41% Silicone Hydrogel Soft Contact Lenses(SHSCL), ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens, Contact Lens Care Product, Contact Lens Case
Keywords
Nearsightedness, Eye wear, Myopia control, Contact lens
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 41% Silicone Hydrogel Soft Contact Lenses(SHSCL)Device

    Silicone Hydrogel

  • ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact LensDevice

    Senofilcon C (USFDA Device License #K160212)

  • Contact Lens Care ProductOther

    Also called Opti-Free Replenish Multi-purpose Disinfecting Solution

    Cefatrizine (propylene Glycol), Sodium Citrate (sodium Citrate Tribasic), Sodium Chloride, Sodium Borate (sodium Biboratesodium Tetraborate, Polyquaternium -1, Hydrochloric Acid, Sodium Hydroxide, Water Purified ( Eq to Aqueous Purified Or Purified Water ), Tetronic 1304, Myristamidopropyl Dimethylamine, Nonanoyl Ethylenediaminetriacetic Acid

  • Contact Lens CaseOther

    Also called "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)

    "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)

Study groups in NCT04226560
Study groupRoleWhat they receive
41% Silicone hydrogel Soft contact lenses (SHSCL)ExperimentalHealthy adult males or females age ≥20-45 years of age
Receives: Device: 41% Silicone Hydrogel Soft Contact Lenses(SHSCL); Other: Contact Lens Care Product; Other: Contact Lens Case
ACUVUE® VITA™Active comparatorHealthy adult males or females age ≥20-45 years of age
Receives: Device: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens; Other: Contact Lens Care Product; Other: Contact Lens Case

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best-corrected contact lens visual acuity

    The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of 0.8 decimal (+0.10 logMAR) and 1.0 decimal (0.00 logMAR) or better.

    The Snellen chart will be used for visual acuity testing.

    Measured: 13 weeks

  2. Permanent loss of visual acuity

    The primary safety endpoint in this evaluation is the percentage of subjects with permanent loss of two or more lines of visual acuity.

    Measured: 13 weeks

  3. 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: 13 weeks

Secondary outcomes (4)

  1. Lens comfort

    The secondary efficacy endpoint is the assessment of lens comfort over time with the lens for the recommended wearing time. This will be measured using Study Diary.

    Subject will be given a Study Diary to be completed at home, to reflect their lens wear experience at the time of rating. Subject will be given careful explanation of how and when to complete them.

    Comfort after insertion (i.e. after lens settling), after 4 hours, and just before lens removal (0-10 scale)(10 = cannot be felt, 0 = painful)

    Measured: 13 weeks

  2. Symptoms of dryness

    The secondary efficacy endpoint is the assessment of dryness symptoms with the lens for the recommended wearing time. This will be measured using Study Diary.

    Subject will be given a Study Diary to be completed at home, to reflect their lens wear experience at the time of rating. Subject will be given careful explanation of how and when to complete them.

    Dryness after insertion (i.e. after lens settling), after 4 hours, and just before lens removal (0-10 scale)(10 = cannot be felt, 0 = painful)

    Measured: 13 weeks

  3. Slit lamp findings

    The secondary efficacy endpoint is the assessment of the rate of any Slit Lamp Findings > Grade 2.

    The subject will be instructed to take off the study lenses before the slit-lamp biomicroscopy assessment.

    Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF.

    ISO 11980:2012 Annex B will be used to grade the Slit-lamp findings.

    Measured: 13 weeks

  4. Subject reported ocular complaints

    Subjects will be asked to assess ocular complaints by using Study Diary.

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start20 Apr 2020
  3. Primary completion30 May 2021 (estimated)
  4. Study completion30 May 2021 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226560
Sponsor's protocol ID
ApexLens-201901
Status last verified
Feb 2021
First submitted
2 Jan 2020
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dumbleton KA, Woods CA, Jones LW, Fonn D. The relationship between compliance with lens replacement and contact lens-related problems in silicone hydrogel wearers. Cont Lens Anterior Eye. 2011 Oct;34(5):216-22. doi: 10.1016/j.clae.2011.03.001. Epub 2011 Apr 13.

    PubMed 21493121

Questions about this trial

What is this clinical trial studying?

A study testing 41% Silicone Hydrogel Soft Contact Lenses(SHSCL), ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens and Contact Lens Care Product in people with Myopia, run by ApexLens Co., Ltd. at 1 site in Taiwan.

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 19 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rex Tsou (886-3-5752910 ext. 206, rex.tsou@apexlens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best-corrected contact lens visual acuity (time frame: 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226560, which also lists 1 linked publication.

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 24 Feb 2021.

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