Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

NCT01669629 | Completed Results

• 1 other identifier: CR-005199
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 10

Brief Summary

This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Subject Reported Ease of Removal

  Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.

  6-10 Days

Secondary Outcomes (4)

• Subject Reported Overall Comfort

  6-10 Days

• Subject Reported Overall Vision

  6-10 Days

• Binocular Snellen Visual Acuity

  6-10 Days

• Overall Corneal Staining

  6-10 Days

Study Arms (2)

Delefilcon A/ Etafilcon A

EXPERIMENTAL

6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear

Device: delefilcon A; Device: etafilcon A

Etafilcon A / Delefilcon A

EXPERIMENTAL

6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear

Device: delefilcon A; Device: etafilcon A

Interventions

delefilcon A DEVICE

Daily wear soft contact lens for bilateral distance vision correction use.

Delefilcon A/ Etafilcon A; Etafilcon A / Delefilcon A

etafilcon A DEVICE

Daily wear soft contact lens for bilateral distance vision correction use.

Delefilcon A/ Etafilcon A; Etafilcon A / Delefilcon A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
• The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week.
• The subject must be a current successful soft contact lens wearer in both eyes
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye.
• The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.
• The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
• The subject must require a visual correction in both eyes (no monofit or monovision allowed).
• The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
• No amblyopia.
• No evidence of lid abnormality or infection (including blepharitis/meibomitis).
• No conjunctival abnormality or infection.
• No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
• No other active ocular disease.

You may not qualify if:

• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Pregnancy or lactation.
• No extended wear in the last 3 months.
• Diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
• Employee or family member of the staff of the investigational site.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (10)

Unknown Facility

Little Rock, Arkansas, 72116, United States

Location

Unknown Facility

Bridgeport, Connecticut, 06610, United States

Location

Unknown Facility

Tampa, Florida, 33625, United States

Location

Unknown Facility

Blue Springs, Missouri, 64015, United States

Location

Unknown Facility

Vestal, New York, 13850, United States

Location

Unknown Facility

Raleigh, North Carolina, 27615, United States

Location

Unknown Facility

Kittanning, Pennsylvania, 16201, United States

Location

Unknown Facility

Warwick, Rhode Island, 02888, United States

Location

Unknown Facility

Chamberlain, South Dakota, 57325, United States

Location

Unknown Facility

Bartlett, Tennessee, 38134, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist
• Organization: Vistakon

kosborn@its.jnj.com

904 443-1032

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: August 16, 2012
• First Posted: August 21, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 19, 2018
• Results First Posted: June 4, 2014

Record last verified: 2016-03

Locations

US (10)