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

NCT03139201 | Completed

• 1 other identifier: 1040625M
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myopia

Keywords

silicone hydrogel soft contact lens

Outcome Measures

Primary Outcomes (1)

• Log MAR visual acuity (VA)

  the visual acuity corrected with contact lens could reach 0.1 or better

  one month

Secondary Outcomes (2)

• Any slit lamp findings > grade 2

  over all follow-up visits for the 1 month

• Subjective response to comfort, symptoms and complaints

  over all follow-up visits for the 1 month

Study Arms (2)

OxyAqua

EXPERIMENTAL

OxyAqua (olifilcon D) daily disposable

Device: OxyAqua

Si-Hy

ACTIVE COMPARATOR

Si-Hy (olifilcon B) daily disposable

Device: Si-Hy

Interventions

OxyAqua DEVICE

OxyAqua (olifilcon D) silicone hydrogel soft contact lens

OxyAqua

Si-Hy DEVICE

Si-Hy (oliflcon B) silicone hydrogel soft contact lens

Si-Hy

Eligibility Criteria

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

You may qualify if:

• 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:
• No anterior segment infection, inflammation or abnormality.
• No other active ocular or systemic disease that would contraindicate contact lens wear; and
• No medications that would contraindicate contact lens wear.
• VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Visco Vision Inc.: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Huey Chuan Cheng, MD MDS

  Mackay Memorial Hospital

  STUDY DIRECTOR

• Shu-I Yeh, MD MS

  MacKay Memorial Hospital - Tamshui

  PRINCIPAL INVESTIGATOR

• Jy Been Liang, MD

  Tri-Service General Hopsital - Tingjhou Branch

  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, 2017
• First Posted: May 3, 2017
• Study Start: September 21, 2016
• Primary Completion: December 8, 2016
• Study Completion: December 8, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share