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OpenTrials
Completed

NCT Number: NCT02815735

Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

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Key information

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eyesite, Reading, Berkshire, United Kingdom

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About this study

This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
  • Adapted soft CL wearers (i.e. >1 month) who are reusable lens wearers*
  • Spectacle cylinder 0.75D in both eyes
  • Correctable to 6/9 in both eyes
  • Be between 18 and 34 years of age (inclusive)
  • Able to read, comprehend and sign an informed consent
  • Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm
  • Willing to comply with the wear and study visit schedule

Exclusion criteria

Any of the following will render a subject ineligible for inclusion:

  • Existing wearer of daily disposable contact lenses
  • Known allergy to Opti-Free PureMoist multipurpose solution
  • Any active corneal infection, injury or inflammation
  • Systemic or ocular allergies, which might interfere with CL wear
  • Systemic disease, which might interfere with CL wear
  • Ocular disease, which might interfere with CL wear
  • Strabismus or amblyopia
  • Subjects who have undergone corneal refractive surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
  • Pregnant, planning a pregnancy or lactating
  • Use of systemic/topical medication contraindicating CL wear
  • Diabetic
  • Site employees or family members of investigators
  • Participation in any concurrent trial or in the last 30 days

Treatment and study plan

comfilcon A

Device

contact lens

lotrafilcon B

Device

contact lens

Primary outcomes

  1. Comfort

    Time frame: Baseline, 2 weeks, 4 weeks

    Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.

  2. Comfort During the Day

    Time frame: Days 3, 12, 26

    Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
May 8, 2017

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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