the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens

NCT ID: NCT03934788

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2018-11-29

Brief Summary

The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.

Detailed Description

This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Oxysoft

olifilcon C, daily disposable soft contact lens, 1 month

Group Type: EXPERIMENTAL

oxysoft (olifilcon C)

Intervention Type: DEVICE

subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.

SiHy

olifilcon B, dialy disposable soft contact lens, 1 month

Group Type: ACTIVE_COMPARATOR

Si-Hy (olifilcon B)

Intervention Type: DEVICE

subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.

Interventions

oxysoft (olifilcon C)

subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.

Intervention Type: DEVICE

Si-Hy (olifilcon B)

subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject should have normal eye and use no ocular medications
• VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 2.00 D
• Willing to comply with all study procedures and be available for the duration of the study.
• Provide signed and dated informed consent form.

Exclusion Criteria

• Subjects have history of allergies that would contraindicate "normal" contact lens wear.
• Subjects have other active ocular or systemic disease such as, but not limited to: anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes, slip lamp findings greater than grade I (such as cornea or interstitial edema).
• Subjects have medications that would contraindicate contact lens wear.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
• A history of papillary conjunctivitis that has interfered with contact lens wear.
• Any active participation in another clinical trial within 30 days prior to this study.
• Have had any cornea surgery.
• Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
• Monocular or monovision fits
• Alcoholic or Drug Abused.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jens Medical Consulting Ltd.

UNKNOWN

Sponsor Role: collaborator

Visco Vision Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huey Chuan Cheng, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation

New Taipei City, , Taiwan

Tri-Service General Hospital_Tingjhou

Taipei, , Taiwan

MayKay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

1060510M

Identifier Type: -

Identifier Source: org_study_id