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Clinical Evaluation of Daily Disposable Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
filcon II 3
etafilcon A
nelfilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

etafilcon A lens

nelfilcon A lens

filcon II 3 lens

Arm Description

Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.

Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.

Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.

Outcomes

Primary Outcome Measures

Overall Lens Preference - All Study Lenses
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).
Overall Lens Preference - Hydrogel vs. Filcon II 3
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 Outcome Measures

Subjective Response for Comfort
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)
Subjective Response for Vision
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).
Subjective Response for Insertion
Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Subjective Response for Handling (Insertion and Removal)
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).
Subjective Response for Dryness
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).
Overall Satisfaction, Vision
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.
Overall Satisfaction, Comfort
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.
Overall Satisfaction, Handling
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.
Overall Satisfaction, Dryness
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.
Overall Satisfaction
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.
Lens Fit and Performance - Wettability (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).
Lens Fit and Performance - Deposits (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);
Lens Fit and Performance - Debris (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)
Lens Fit and Performance - Movement (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).
Lens Fit and Performance - Fit Acceptance
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).
Lens Fit and Performance - Tightness (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).
Ocular Health - Biomicroscopy
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)

Full Information

First Posted
March 24, 2014
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02097030
Brief Title
Clinical Evaluation of Daily Disposable Contact Lenses
Official Title
Single-Center Clinical Evaluation of Daily Disposable Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A lens
Arm Type
Active Comparator
Arm Description
Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
Arm Title
nelfilcon A lens
Arm Type
Active Comparator
Arm Description
Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
Arm Title
filcon II 3 lens
Arm Type
Active Comparator
Arm Description
Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
Intervention Type
Device
Intervention Name(s)
filcon II 3
Other Intervention Name(s)
Silicone Hydrogel Daily Disposable Contact Lens
Intervention Description
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Other Intervention Name(s)
Hydrogel Daily Disposable Contact Lens
Intervention Description
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Other Intervention Name(s)
Hydrogel Daily Disposable Contact Lens
Intervention Description
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
Primary Outcome Measure Information:
Title
Overall Lens Preference - All Study Lenses
Description
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).
Time Frame
Study Exit
Title
Overall Lens Preference - Hydrogel vs. Filcon II 3
Description
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).
Time Frame
Study Exit
Secondary Outcome Measure Information:
Title
Subjective Response for Comfort
Description
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)
Time Frame
Baseline and 3 day follow-up
Title
Subjective Response for Vision
Description
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).
Time Frame
Baseline and 3 day follow-up
Title
Subjective Response for Insertion
Description
Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Time Frame
Baseline
Title
Subjective Response for Handling (Insertion and Removal)
Description
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).
Time Frame
3 days follow-up
Title
Subjective Response for Dryness
Description
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).
Time Frame
3 Days Follow-up
Title
Overall Satisfaction, Vision
Description
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.
Time Frame
3 Days Follow-up
Title
Overall Satisfaction, Comfort
Description
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.
Time Frame
3 Days Follow-up
Title
Overall Satisfaction, Handling
Description
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.
Time Frame
3 Days
Title
Overall Satisfaction, Dryness
Description
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.
Time Frame
3 Days Follow-up
Title
Overall Satisfaction
Description
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.
Time Frame
3 Days Follow-up
Title
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)
Description
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).
Time Frame
Baseline and 3 days follow-up
Title
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)
Description
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);
Time Frame
Baseline and 3 days follow-up
Title
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)
Description
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)
Time Frame
Baseline and 3 day follow-up
Title
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)
Description
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).
Time Frame
Baseline and 3 days follow-up
Title
Lens Fit and Performance - Fit Acceptance
Description
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).
Time Frame
Baseline and 3 day follow-up
Title
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)
Description
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).
Time Frame
Baseline and 3 day follow-up
Title
Ocular Health - Biomicroscopy
Description
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)
Time Frame
3 Days Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng C Lin, OD, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Berkeley Clinical Research Center (UCB-CRC)
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-2020
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Daily Disposable Contact Lenses

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