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Completed

NCT Number: NCT01707238

Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keith Tempany Opticians, Broadstone, Dorset, United Kingdom

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About this study

The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-

  • Be between 16 and 45 years of age (inclusive)
  • Adapted soft contact lens (CL) wearers (i.e. > 1 month)
  • Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
  • Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
  • Correctable to 6/9 (20/30) in both eyes
  • Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
  • Have read, understood and signed the informed consent
  • Willing to comply with the wear schedule (at least 40 hours per week)
  • Willing to comply with the study visit schedule

Exclusion criteria

-

  • 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, amblyopia
  • Subjects who have undergone corneal refractive surgery and any anterior segment surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
  • Pregnant or lactating
  • Use of systemic/topical medication contraindicating CL wear
  • Use of gas permeable contact lenses within the last month
  • Employees of the investigational site or immediate family members of Investigators
  • Participation in any concurrent clinical trial or in the last 30 days

Treatment and study plan

etafilcon A

Device

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Other names: etafilcon A (Daily Disposable Contact Lens)

stenfilcon A

Device

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Other names: stenfilcon A (Daily Disposable Contact Lens)

Primary outcomes

  1. Handling

    Time frame: two weeks and four weeks from baseline visit

    Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).

  2. Satisfaction With Handling

    Time frame: two weeks and four weeks from baseline visit

    Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

Secondary outcomes

  1. Comfort

    Time frame: two weeks and four weeks from baseline visit

    Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).

  2. Dryness

    Time frame: two weeks and four weeks from baseline visit

    Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).

  3. Satisfaction With Dryness

    Time frame: two weeks and four weeks from baseline visit

    Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

  4. Satisfaction With Comfort

    Time frame: two weeks and four weeks from baseline visit

    Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2012
Registry last updated
Aug 3, 2020

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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