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

NCT03934788 | Completed

• 1 other identifier: 1060510M
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Myopia

Keywords

contact lens material; silicon hydrogel

Outcome Measures

Primary Outcomes (1)

• Log MAR visual acuities

  The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.

  1 month

Secondary Outcomes (1)

• slit lamp findings

  1 month

Study Arms (2)

Oxysoft

EXPERIMENTAL

olifilcon C, daily disposable soft contact lens, 1 month

Device: oxysoft (olifilcon C)

SiHy

ACTIVE COMPARATOR

olifilcon B, dialy disposable soft contact lens, 1 month

Device: Si-Hy (olifilcon B)

Interventions

oxysoft (olifilcon C) DEVICE

subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.

Oxysoft

Si-Hy (olifilcon B) DEVICE

subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.

SiHy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Visco Vision Inc.: lead
• Jens Medical Consulting Ltd.: collaborator

Study Sites (3)

Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation

New Taipei City, 231, Taiwan

Location

Tri-Service General Hospital_Tingjhou

Taipei, 100, Taiwan

Location

MayKay Memorial Hospital

Taipei, 10449, Taiwan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Huey Chuan Cheng, MD MSc

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 2, 2019
• Study Start: September 26, 2018
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)