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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: oxysoft (olifilcon C); Device: Si-Hy (olifilcon B)

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.

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

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 231
    • Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation
  • Taipei, Taiwan, 100
    • Tri-Service General Hospital_Tingjhou
  • Taipei, Taiwan, 10449
    • MayKay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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: Oxysoft; olifilcon C, daily disposable soft contact lens, 1 month	Device: oxysoft (olifilcon C); subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.
Active Comparator: SiHy; olifilcon B, dialy disposable soft contact lens, 1 month	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log MAR visual acuities	The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
slit lamp findings	Any slit lamp findings > grade 2 [ Time Frame: over all follow-up visits for the 1 month ] 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.	1 month

Collaborators and Investigators

• Sponsor: Visco Vision Inc.
• Collaborators: Jens Medical Consulting Ltd.
• Investigators: Principal Investigator: Huey Chuan Cheng, MD MSc, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: contact lens material; silicon hydrogel
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 1060510M

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