Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses

Comparison of Clinical Performance and Subjective Preference Out of Three Cosmetic Contact Lenses (Limbal Ring-enhancing Lenses, LRE Lenses)

The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: etafilcon A; Device: methafilcon A - Interozzo; Device: methafilcon A - CVI (CooperVision)

Detailed Description

This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
• Existing soft contact lens wearers or previous experience of contact lens wear
• Being able to wear the study lenses for at least eight hours a day
• At least 6/9 visual acuity in each eye with the study lenses
• Astigmatism less than 1.50 D (Diopter) in both eyes
• Agreed to follow the protocol and not to participate in other clinical research for the duration of this study

Exclusion Criteria:

• Have an ocular disorder which would normally contraindicate contact lens wear
• Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
• Have previously had any ocular surgery such as corneal refractive surgery
• Have less than 6/9 visual acuity in each eye with the study lenses
• Are currently using any topical medication such as eye drops or ointment
• Have any corneal distortion resulting from previous rigid lens wear or have keratoconus
• Are currently pregnant or lactating
• No previous contact lens wear

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: etafilcon A	Device: etafilcon A; contact lens
Active Comparator: methafilcon A - Interozzo	Device: methafilcon A - Interozzo; contact lens
Active Comparator: methafilcon A - CVI	Device: methafilcon A - CVI (CooperVision); contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.	1 week per intervention

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): June 24, 2017
• Study Completion (Actual): June 24, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV_BSCHU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No