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Completed

NCT Number: NCT02097030

Clinical Evaluation of Daily Disposable Contact Lenses

The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Berkeley Clinical Research Center (UCB-CRC)

Berkeley, California, 94720-2020, United States

About this study

Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft CL wearer
  • Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
  • Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
  • Has less than 1.25 D spectacle cylinder in each eye.
  • Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter
  • Is willing to comply with the wear schedule (at least 3 full days)
  • Is willing to comply with the visit schedule

Exclusion criteria

  • Has never worn contact lenses before.
  • Currently wears rigid gas permeable contact lenses.
  • Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)
  • Has a CL prescription outside the range of - 1.00 to -6.00D
  • Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
  • Has best corrected spectacle distance vision worse then 20/25 in either eye.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars.
  • Is aphakic.
  • Is presbyopic.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

Treatment and study plan

filcon II 3

Device

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

Other names: Silicone Hydrogel Daily Disposable Contact Lens

etafilcon A

Device

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

Other names: Hydrogel Daily Disposable Contact Lens

Nelfilcon A

Device

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

Other names: Hydrogel Daily Disposable Contact Lens

Primary outcomes

  1. Overall Lens Preference - All Study Lenses

    Time frame: Study Exit

    Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).

  2. Overall Lens Preference - Hydrogel vs. Filcon II 3

    Time frame: Study Exit

    Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).

Secondary outcomes

  1. Subjective Response for Comfort

    Time frame: Baseline and 3 day follow-up

    Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)

  2. Subjective Response for Vision

    Time frame: Baseline and 3 day follow-up

    Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).

  3. Subjective Response for Insertion

    Time frame: Baseline

    Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).

  4. Subjective Response for Handling (Insertion and Removal)

    Time frame: 3 days follow-up

    Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).

  5. Subjective Response for Dryness

    Time frame: 3 Days Follow-up

    Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).

  6. Overall Satisfaction, Vision

    Time frame: 3 Days Follow-up

    Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

  7. Overall Satisfaction, Comfort

    Time frame: 3 Days Follow-up

    Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

  8. Overall Satisfaction, Handling

    Time frame: 3 Days

    Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

  9. Overall Satisfaction, Dryness

    Time frame: 3 Days Follow-up

    Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

  10. Overall Satisfaction

    Time frame: 3 Days Follow-up

    Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

  11. Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)

    Time frame: Baseline and 3 days follow-up

    The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).

  12. Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)

    Time frame: Baseline and 3 days follow-up

    The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);

  13. Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)

    Time frame: Baseline and 3 day follow-up

    The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)

  14. Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)

    Time frame: Baseline and 3 days follow-up

    The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).

  15. Lens Fit and Performance - Fit Acceptance

    Time frame: Baseline and 3 day follow-up

    The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).

  16. Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)

    Time frame: Baseline and 3 day follow-up

    The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).

  17. Ocular Health - Biomicroscopy

    Time frame: 3 Days Follow-up

    The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Single-Center Clinical Evaluation of Daily Disposable Contact Lenses

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2014
Registry last updated
Jul 31, 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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