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OpenTrials
Completed

NCT Number: NCT03134599

Comparison of Clinical Performance and Subjective Preference of Three Contact 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Daegu, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etafilcon A

Device

contact lens

methafilcon A - Interozzo

Device

contact lens

methafilcon A - CVI (CooperVision)

Device

contact lens

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 1, 2017
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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