Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676258
• Other study ID #: 1030313M
• Status: Completed
• Phase: N/A
• First received: January 30, 2016
• Last updated: July 5, 2016
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Visco Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.

Description:

This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subject should have normal eyes and use no ocular medications

• Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism

• VA correctable to Log MAR 0.1 or better.

• 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.

• Subjects have medications that would contraindicate contact lens wear.

• Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month.

• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Si-Hy (olifilcon B)
Wear Si-Hy silicone hydrgel soft contact lens for 3 months
• Vistakon (narafilcon A)
Wear Vistakon soft contact lens for 3 months

Locations

Country	Name	City	State
Taiwan	MayKay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Visco Vision Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	logMAR visual acuity (VA) over all visits.	over all follow-up visits for 3 month study period	No
Secondary	Any Slit Lamp Finding > Grade 2	All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.	over all follow-up visits for the 3 month study period	Yes
Secondary	Subjective Response to Comfort, symptoms and complaints	subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.	over all follow-up visits for the 3 month study period	Yes