Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: etafilcon A; Device: methafilcon A - Interozzo; Device: methafilcon A - CVI (CooperVision)

• Registration Number: NCT03134599
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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).

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 Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Study Start: 2017-05-23
• Primary Completion: 2017-06-24
• Study Completion: 2017-06-24
• Results First Submitted: 2018-07-26
• Results First Submitted QC: 2019-02-21
• Results First Posted: 2019-02-22
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
etafilcon A	etafilcon A	-
methafilcon A - Interozzo	methafilcon A - Interozzo	-
methafilcon A - CVI	methafilcon A - CVI (CooperVision)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep); 🇰🇷 Daegu, Korea, Republic of