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

NCT ID: NCT03139201

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-21
• Study Completion Date: 2016-12-08

Brief Summary

The objective of this study is to demonstrate that the OxyAqua 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 from one hospital. 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

OxyAqua

OxyAqua (olifilcon D) daily disposable

Group Type: EXPERIMENTAL

OxyAqua

Intervention Type: DEVICE

OxyAqua (olifilcon D) silicone hydrogel soft contact lens

Si-Hy

Si-Hy (olifilcon B) daily disposable

Group Type: ACTIVE_COMPARATOR

Si-Hy

Intervention Type: DEVICE

Si-Hy (oliflcon B) silicone hydrogel soft contact lens

Interventions

OxyAqua

OxyAqua (olifilcon D) silicone hydrogel soft contact lens

Intervention Type: DEVICE

Si-Hy

Si-Hy (oliflcon B) silicone hydrogel soft contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects should have normal eyes and use no ocular medications. They may have worn contact lenses previously, provided their eyes are shown to be normal at the start of the investigation. A normal eye is defined as having the following characteristics:

1. No anterior segment infection, inflammation or abnormality.

2. No other active ocular or systemic disease that would contraindicate contact lens wear; and

3. No medications that would contraindicate contact lens wear.

• VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from
• 1.00 to -10.00 D myopia, astigmatism less than 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

• Have history of allergies that would contraindicate "normal" contact lens wear.
• 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).
• Have medications that would contraindicate contact lens wear.
• 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.
• Any active participation in another clinical trial within 30 days prior to this study.
• 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.
• No monocular or monovision fits.
• Alcoholic or Drug Abused.

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

Sponsors

Visco Vision Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huey Chuan Cheng, MD MDS

Role: STUDY_DIRECTOR

Mackay Memorial Hospital

Shu-I Yeh, MD MS

Role: PRINCIPAL_INVESTIGATOR

MacKay Memorial Hospital - Tamshui

Jy Been Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hopsital - Tingjhou Branch

Other Identifiers

1040625M

Identifier Type: -

Identifier Source: org_study_id