NCT04226560

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

January 2, 2020

Last Update Submit

February 23, 2021

Conditions

Myopia

Keywords

NearsightednessEye wearMyopia controlContact lens

Outcome Measures

Primary Outcomes (3)

  • 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.

    13 weeks

  • 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.

    13 weeks

  • 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.

    13 weeks

Secondary Outcomes (4)

  • Lens comfort

    13 weeks

  • Symptoms of dryness

    13 weeks

  • Slit lamp findings

    13 weeks

  • Subject reported ocular complaints

    13 weeks

Study Arms (2)

41% Silicone hydrogel Soft contact lenses (SHSCL)

EXPERIMENTAL

Healthy adult males or females age ≥20-45 years of age

Device: 41% Silicone Hydrogel Soft Contact Lenses(SHSCL)Other: Contact Lens Care ProductOther: Contact Lens Case

ACUVUE® VITA™

ACTIVE COMPARATOR

Healthy adult males or females age ≥20-45 years of age

Device: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact LensOther: Contact Lens Care ProductOther: Contact Lens Case

Interventions

41% Silicone Hydrogel Soft Contact Lenses(SHSCL)DEVICE

Silicone Hydrogel

41% Silicone hydrogel Soft contact lenses (SHSCL)
ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact LensDEVICE

Senofilcon C (USFDA Device License #K160212)

ACUVUE® VITA™
Contact Lens Care ProductOTHER

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

Also known as: Opti-Free Replenish Multi-purpose Disinfecting Solution
41% Silicone hydrogel Soft contact lenses (SHSCL)ACUVUE® VITA™
Contact Lens CaseOTHER

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

Also known as: "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
41% Silicone hydrogel Soft contact lenses (SHSCL)ACUVUE® VITA™

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ApexLens Co., Ltd.

Hsinchu, 300, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21493121RESULT

MeSH Terms

Conditions

Myopia

Interventions

Contact LensesHydrophobic and Hydrophilic Interactions

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesChemical Phenomena

Study Officials

  • Yih-Shiou Hwang, M.D.,Ph.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Hsin-Wei Huang, M.D.

    Taipei Medical University - Municipal Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rex Tsou

CONTACT

886-3-5752910rex.tsou@apexlens.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 13, 2020

Study Start

April 20, 2020

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)