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Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stenfilcon A
delefilcon A
narafilcon 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 spherical contact lens wearer
  • Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
  • Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter
  • Patient contact lens refraction should fit within the available parameters of the study lenses
  • Is willing to comply with the wear schedule
  • Is willing to comply with the visit schedule

Exclusion Criteria:

  • Is not a habitual wearer of soft spherical contact lenses
  • Has a contact lens prescription outside the range of the available parameters of the study lenses
  • Has a contact lens prescription outside the range of the inclusion power range
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye
  • Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
  • Presence of clinically significant (grade > 2) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear

  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Moderate to severe dry eye
    • Pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (past or present)
    • Seborrheic eczema, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea
  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses
  • Has undergone corneal refractive surgery
  • Is participating in any other type of eye related clinical or research study

Sites / Locations

  • Clinical Research Center, University of California, Berkeley

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

stenfilcon A and delefilcon A

stenfilcon A and narafilcon A

Arm Description

Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.

Participants randomized wear the stenfilcon A and the narafilcon A contralaterally

Outcomes

Primary Outcome Measures

Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)
Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).

Secondary Outcome Measures

Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).
Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).
Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).
Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)

Full Information

First Posted
January 14, 2015
Last Updated
January 30, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02341859
Brief Title
Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Official Title
Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (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
Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Detailed Description
The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.

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
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stenfilcon A and delefilcon A
Arm Type
Active Comparator
Arm Description
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
Arm Title
stenfilcon A and narafilcon A
Arm Type
Active Comparator
Arm Description
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
Intervention Type
Device
Intervention Name(s)
stenfilcon A
Other Intervention Name(s)
MyDay
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
delefilcon A
Other Intervention Name(s)
1-DAY ACUVUE
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
narafilcon A
Other Intervention Name(s)
DAILIES TOTAL1
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time Frame
Baseline
Title
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time Frame
6 hours
Title
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time Frame
Baseline
Title
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time Frame
6 hours
Title
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time Frame
Baseline
Title
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time Frame
6 hours
Title
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time Frame
Baseline
Title
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time Frame
6 hours
Title
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time Frame
Baseline
Title
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time Frame
6 hours
Title
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time Frame
Baseline
Title
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time Frame
6 hours
Title
Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)
Time Frame
6 hours
Title
Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)
Time Frame
6 hours
Title
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.
Time Frame
Baseline
Title
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.
Time Frame
6 hours
Title
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Time Frame
Baseline
Title
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Time Frame
6 hours
Title
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)
Time Frame
Baseline
Title
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)
Time Frame
6 hours
Title
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Time Frame
Baseline
Title
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)
Time Frame
6 hours
Title
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)
Time Frame
Baseline
Title
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)
Time Frame
6 hours
Title
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Time Frame
Baseline
Title
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time Frame
Baseline
Title
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time Frame
6 hours
Title
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time Frame
Baseline
Title
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time Frame
6 hours
Title
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time Frame
6 hours
Title
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).
Time Frame
Baseline, 3 hours, 6 hours
Title
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).
Time Frame
Baseline, 3 hours, 6 hours
Title
Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).
Time Frame
Baseline and 6 hours
Title
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).
Time Frame
Baseline, 3 hours, 6 hours
Title
Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).
Time Frame
6 hours
Title
Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Description
Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)
Time Frame
6 hours

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 spherical contact lens wearer Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive) Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter Patient contact lens refraction should fit within the available parameters of the study lenses Is willing to comply with the wear schedule Is willing to comply with the visit schedule Exclusion Criteria: Is not a habitual wearer of soft spherical contact lenses Has a contact lens prescription outside the range of the available parameters of the study lenses Has a contact lens prescription outside the range of the inclusion power range Has a spectacle cylinder ≥1.00D of cylinder in either eye Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye Presence of clinically significant (grade > 2) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear Slit lamp findings that would contraindicate contact lens wear such as: Moderate to severe dry eye Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea Has Presbyopia or has dependence on spectacles for near work over the contact lenses 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
CRC-UC Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

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