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Clinical Trials/NCT03134599
NCT03134599
Completed
Not Applicable

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

Coopervision, Inc.1 site in 1 country60 target enrollmentMay 23, 2017
ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Coopervision, Inc.
Enrollment
60
Locations
1
Primary Endpoint
Comfort
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2017
End Date
June 24, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Comfort

Time Frame: 1 week per intervention

Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.

Study Sites (1)

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