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

A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxyAqua Silicone Hydrogel Soft Contact Lens

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: OxyAqua; Device: Si-Hy

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OxyAqua; OxyAqua (olifilcon D) daily disposable	Device: OxyAqua; OxyAqua (olifilcon D) silicone hydrogel soft contact lens
Active Comparator: Si-Hy; Si-Hy (olifilcon B) daily disposable	Device: Si-Hy; Si-Hy (oliflcon B) silicone hydrogel soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log MAR visual acuity (VA)	the visual acuity corrected with contact lens could reach 0.1 or better	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any slit lamp findings > grade 2	slit lamp findings on all dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.	over all follow-up visits for the 1 month
Subjective response to comfort, symptoms and complaints	subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 5=No stinging/Burning for each eye	over all follow-up visits for the 1 month

Collaborators and Investigators

• Sponsor: Visco Vision Inc.
• Investigators: Study Director: Huey Chuan Cheng, MD MDS, Mackay Memorial Hospital; Principal Investigator: Shu-I Yeh, MD MS, MacKay Memorial Hospital - Tamshui; Principal Investigator: Jy Been Liang, MD, Tri-Service General Hopsital - Tingjhou Branch

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): December 8, 2016
• Study Completion (Actual): December 8, 2016

Study Registration Dates

• First Submitted: April 29, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: silicone hydrogel soft contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 1040625M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No