Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

Myopia Clinical Trial

Official title:

A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of VISCO Soft Contact Lens on a Daily Wear Basis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354924
• Other study ID #: 1000601M
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: July 5, 2016
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2016
• Source: Visco Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• 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 -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.

Exclusion Criteria:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Biofinity soft contact lens
Biofinity soft contact lens or one of the study lenses 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
Viso soft contact lens or one of the study lenses 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Visco Vision Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity	Distant Visual acuity correctable to 20/25 or better and 90% of total subject with visual alteration is less than 2 lines in the Snellen chart.	over all follow up visit for 3 months study period	No
Secondary	Slit Lamp Findings	Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Edema, corneal neovascularization, corneal staining, Injection, tarsal abnormalities, and other complications were measured.	over all follow up visit for 3 month study period	Yes
Secondary	symptoms, problems and complaints and incidence rate	Incident rate for Subjective Responses to comfort/symptoms/complaints were measured at every visit. Questionnaire for subjective comfort is assessed at final visit for comfort, watery, photophobia, halos, itchy/burning, spectacle blur, variable vision, blurred vision, lens needs cleaning and over all lens preference. The scale for questionnaire is 1=Severe Burning to 10=No Burning for each eye; 10 represented the least favorable rating and 100 represented the most favorable rating.	over all follow up visit for 3 month study period	Yes