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

Purpose

Primary Hypothesis:

After 1-week of wear, etafilcon A will be non-inferior to delefilcon A in terms of ease of lens removal. The non-inferiority odds ratio margin is set assuming a reference rate for the etafilcon A lens and a 10% difference between etafilcon A and delefilcon A.

Secondary Hypotheses:

After 1-week of wear, etafilcon A will be non-inferior to delefilcon A in terms of overall comfort. The non-inferiority odds ratio margin is set assuming a reference rate for the etafilcon A lens and a 10% difference between etafilcon A and delefilcon A.
After 1-week of wear, etafilcon A will be non-inferior to delefilcon A in terms of overall vision. The non-inferiority odds ratio margin is set assuming a reference rate for the etafilcon A lens and a 10% difference between etafilcon A and delefilcon A.
After 1-week of wear, the binocular, Snellen Visual Acuity of etafilcon Awill be non-inferior to delefilcon A in terms of the percentage of eyes with 20/20-2 letter vision or better. The non-inferiority odds ratio margin is set assuming a reference rate for the etafilcon A lens and a 10% difference between etafilcon A and delefilcon A.
After 1-week of wear, the corneal staining with etafilcon A will be non-inferior to delefilcon A based on the presence of corneal staining ( Grade '1' '2' '3' or '4') versus absence of corneal staining (Grade '0') in all five ocular regions. The non-inferiority odds ratio margin is set assuming a reference rate for the etafilcon A lens and a 10% difference between etafilcon A and delefilcon A.

Condition	Intervention
Myopia	Device: delefilcon A Device: etafilcon A

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:

Subject Reported Ease of Removal [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using a non-inferiority odds-ratio margin.

Secondary Outcome Measures:

Subject Reported Overall Comfort [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using a non-inferiority odds-ratio margin.
Subject Reported Overall Vision [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using a non-inferiority odds-ratio margin.
Binocular Snellen Visual Acuity [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
Snellen visual acuity percentage of eyes with a visual acuity of 20/20-2 or better by eye.
Overall corneal staining [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
Proportion of subjects that have corneal staining on the 0-4 NEI scale measured by eye.

Enrollment:	183
Study Start Date:	August 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sequence 1 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 Daily wear soft contact lens for bilateral distance vision correction use. Device: etafilcon A Daily wear soft contact lens for bilateral distance vision correction use.
Experimental: Sequence 2 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 Daily wear soft contact lens for bilateral distance vision correction use. Device: etafilcon A Daily wear soft contact lens for bilateral distance vision correction use.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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:
1. No amblyopia.
2. No evidence of lid abnormality or infection (including blepharitis/meibomitis).
3. No conjunctival abnormality or infection.
4. No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
5. No other active ocular disease.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669629

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72116
United States, Connecticut

Bridgeport, Connecticut, United States, 06610
United States, Florida

Tampa, Florida, United States, 33625
United States, Missouri

Blue Springs, Missouri, United States, 64015
United States, New York

Vestal, New York, United States, 13850
United States, North Carolina

Raleigh, North Carolina, United States, 27615
United States, Pennsylvania

Kittaning, Pennsylvania, United States, 16201
United States, Rhode Island

Warwick, Rhode Island, United States, 02888
United States, South Dakota

Chamberlain, South Dakota, United States, 57325
United States, Tennessee

Bartlett, Tennessee, United States, 38134

Sponsors and Collaborators

Vistakon

More Information

No publications provided

Responsible Party:	Vistakon
ClinicalTrials.gov Identifier:	NCT01669629 History of Changes
Other Study ID Numbers:	CR-005199
Study First Received:	August 16, 2012
Last Updated:	April 8, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013