Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

NCT02354924 | Completed Results DMC

• 1 other identifier: 1000601M
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Visual acuity correctable to snellen 20/25 or better

  3 months

Secondary Outcomes (2)

• Slit Lamp Findings

  3 month

• Symptoms, Problems and Complaints and Incidence Rate

  3 month

Study Arms (2)

Visco soft contact lens

EXPERIMENTAL

Olifilcon A, Daily wear, monthly disposable soft contact lens

Device: Visco soft contact lens

Biofinity soft contact lens

ACTIVE COMPARATOR

Comfilcon A, Daily wear, monthly disposable soft contact lens

Device: Biofinity soft contact lens

Interventions

Biofinity soft contact lens DEVICE

Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Biofinity soft contact lens

Visco soft contact lens DEVICE

Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Visco soft contact lens

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 eyes and use no ocular medications
• Subject with -1.00 to -10.00 D myopia, less than -1.25 D astigmatism
• VA correctable to 20/25 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.

You may not qualify if:

• Subjects have history of allergies that would contraindicate solution use and/or "normal" contact lens wear.
• Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test \< 5mm/5min or other physical condition that would contraindicate contact lens wear.
• Subjects have other active ocular or systemic disease that would contraindicate contact lens wear.
• Subjects have medications that would contraindicate contact lens wear.
• Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study.
• Current drug or alcohol use or dependence that would interfere with adherence to study requirements.
• Individuals participating in other clinical studies.

Sponsors & Collaborators

• Visco Vision Inc.: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr. Huey-Chuan Cheng
• Organization: Mackay Memorial Hospital_Taipei

hccheng@ms2.mmh.org.tw

886-2-25433535

Study Officials

• Huey Chuan Cheng, MD. MS

  Mackey Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share