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OpenTrials
Completed

NCT Number: NCT02341859

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

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

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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

Clinical Research Center, University of California, Berkeley

Berkeley, California, 94704, United States

About this study

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.

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 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

Treatment and study plan

stenfilcon A

Device

contact lens

Other names: MyDay

delefilcon A

Device

contact lens

Other names: 1-DAY ACUVUE

narafilcon A

Device

contact lens

Other names: DAILIES TOTAL1

Primary outcomes

  1. Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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

  2. Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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

  3. Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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

  4. Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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

  5. Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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

  6. Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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

  7. Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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

  8. Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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

  9. Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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

  10. Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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

  11. Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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

  12. Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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

  13. Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  14. Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  15. Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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'.

  16. Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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'.

  17. Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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)

  18. Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  19. Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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)

  20. Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  21. Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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)

  22. Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  23. Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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)

  24. Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  25. Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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)).

  26. Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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 outcomes

  1. Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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)

  2. Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  3. Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline

    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)

  4. Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  5. Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

  6. Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline, 3 hours, 6 hours

    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).

  7. Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline, 3 hours, 6 hours

    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).

  8. Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline and 6 hours

    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).

  9. Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: Baseline, 3 hours, 6 hours

    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).

  10. Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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).

  11. Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

    Time frame: 6 hours

    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)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
Mar 10, 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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