Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens. - Full Text View

Purpose

The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Condition	Intervention
Astigmatism	Device: Etafilcon A toric contact lens Device: Nelfilcon A toric contact lens

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:

Monocular Visual Acuity on LogMAR Scale [ Time Frame: After 5 to 9 days of lens wear ] [ Designated as safety issue: No ]
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Binocular Visual Acuity on LogMAR Scale [ Time Frame: After 5 to 9 days of lens wear ] [ Designated as safety issue: No ]
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire [ Time Frame: After 5 to 9 days of lens wear ] [ Designated as safety issue: No ]
The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. [ Time Frame: After 5 to 9 days of lens wear ] [ Designated as safety issue: No ]
The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).

Enrollment:	70
Study Start Date:	January 2010
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Etafilcon A toric contact lens/Nelfilcon A toric Etafilcon A toric contact lens first, then nelfilcon A toric second	Device: Etafilcon A toric contact lens contact lens to correct astigmatism Device: Nelfilcon A toric contact lens contact lens to correct astigmatism
Nelfilcon A toric/ Etafilcon A toric Nelfilcon A toric contact lens first, then etafilcon A toric toric second	Device: Etafilcon A toric contact lens contact lens to correct astigmatism Device: Nelfilcon A toric contact lens contact lens to correct astigmatism

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject must be between 18 and 40 years old.
The subject must have normal eyes.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
The subject must be an adapted wearer of soft toric contact lenses in both eyes.
The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria:

Ocular or systemic allergies or disease that may interfere with contact lens wear.
Systemic disease or 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 abnormality of the cornea, which may contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities that 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
Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
Diabetes
Strabismus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055132

Locations

United States, California

Los Angeles, California, United States, 90049
United States, Florida

Jacksonville, Florida, United States, 32256

Jacksonville, Florida, United States, 32205
United States, Georgia

Marietta, Georgia, United States, 30060
United States, New York

New York, New York, United States, 10001
United States, Rhode Island

Warwick, Rhode Island, United States, 02886

Sponsors and Collaborators

Vistakon

More Information

No publications provided

Responsible Party:	Vistakon
ClinicalTrials.gov Identifier:	NCT01055132 History of Changes
Other Study ID Numbers:	CR-1476AG
Study First Received:	January 22, 2010
Results First Received:	November 3, 2011
Last Updated:	March 8, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013