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

NCT02341859 | Completed Results

• 1 other identifier: JP-MKTG-201501
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (26)

• 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

  Baseline

• 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

  6 hours

• 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

  Baseline

• 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

  6 hours

• 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

  Baseline

• 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

  6 hours

• 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

  Baseline

• 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

  6 hours

• 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

  Baseline

• 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

  6 hours

• 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

  Baseline

• 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

  6 hours

• 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)

  6 hours

• 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)

  6 hours

• 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'.

  Baseline

• 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'.

  6 hours

• 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)

  Baseline

• 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)

  6 hours

• 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)

  Baseline

• 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)

  6 hours

• 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)

  Baseline

• 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)

  6 hours

• 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)

  Baseline

• 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)

  6 hours

• 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)).

  Baseline

• 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)).

  6 hours

Secondary Outcomes (11)

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

  Baseline

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

  6 hours

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

  Baseline

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

  6 hours

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

  6 hours

Study Arms (2)

stenfilcon A and delefilcon A

ACTIVE COMPARATOR

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

Device: stenfilcon A; Device: delefilcon A

stenfilcon A and narafilcon A

ACTIVE COMPARATOR

Participants randomized wear the stenfilcon A and the narafilcon A contralaterally

Device: stenfilcon A; Device: narafilcon A

Interventions

stenfilcon A DEVICE

contact lens

Also known as: MyDay

stenfilcon A and delefilcon A; stenfilcon A and narafilcon A

delefilcon A DEVICE

contact lens

Also known as: 1-DAY ACUVUE

stenfilcon A and delefilcon A

narafilcon A DEVICE

contact lens

Also known as: DAILIES TOTAL1

stenfilcon A and narafilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Clinical Research Center, University of California, Berkeley

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Taku Muraoka, OD, Director Professional Services Organization
• Organization: Coopervision Japan

taku.muraoka@jp.coopervision.com

81-3-5449-6619

Study Officials

• Meng C Lin, OD PhD

  CRC-UC Berkeley

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 19, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 10, 2017
• Results First Posted: May 26, 2016

Record last verified: 2017-01

Locations

US (1)