Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedStudy Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2017
CompletedResults Posted
Study results publicly available
February 22, 2019
CompletedDecember 19, 2019
December 1, 2019
1 month
April 26, 2017
July 26, 2018
December 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Comfort
Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
1 week per intervention
Study Arms (3)
etafilcon A
ACTIVE COMPARATORmethafilcon A - Interozzo
ACTIVE COMPARATORmethafilcon A - CVI
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)
Daegu, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jose Vega, O.D., MSc., FAAO
- Organization
- CooperVision
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 1, 2017
Study Start
May 23, 2017
Primary Completion
June 24, 2017
Study Completion
June 24, 2017
Last Updated
December 19, 2019
Results First Posted
February 22, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share