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Performance and Safety of Silicone Hydrogel Soft Contact Lenses

NCT04226560 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-02-24

No results posted yet for this study

Summary

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

Conditions

  • Myopia

Interventions

DEVICE

41% Silicone Hydrogel Soft Contact Lenses(SHSCL)

Silicone Hydrogel

DEVICE

ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens

Senofilcon C (USFDA Device License #K160212)

OTHER

Contact Lens Care Product

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

OTHER

Contact Lens Case

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

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Taipei Medical University WanFang Hospital

    collaborator OTHER

  • ApexLens Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yih-Shiou Hwang, M.D.,Ph.D. · Chang Gung Memorial Hospital

  • Hsin-Wei Huang, M.D. · Taipei Medical University - Municipal Wan Fang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04226560 on ClinicalTrials.gov