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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934788
• Other study ID #: 1060510M
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: November 29, 2018

Study information

• Verified date: April 2019
• Source: Visco Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation	New Taipei City
Taiwan	MayKay Memorial Hospital	Taipei
Taiwan	Tri-Service General Hospital_Tingjhou	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Visco Vision Inc.	Jens Medical Consulting Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Log MAR visual acuities	The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.	1 month
Secondary	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