Clinical trial NCT03934788: the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
Official title: A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens material
silicon hydrogel
Lead sponsor: Visco Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jens Medical Consulting Ltd.
First posted: 2019-05-02
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Log MAR visual acuities
timeFrame: 1 month
Secondary outcomes:
measure: slit lamp findings
timeFrame: 1 month
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital_Tingjhou
city: Taipei
country: Taiwan
facility: MayKay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Huey Chuan Cheng, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: