Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
1 other identifier
interventional
70
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
February 7, 2013
CompletedJune 19, 2018
May 1, 2015
1 month
January 22, 2010
November 3, 2011
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Monocular Visual Acuity on LogMAR Scale
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.
After 5 to 9 days of lens wear
Binocular Visual Acuity on LogMAR Scale
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.
After 5 to 9 days of lens wear
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
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).
After 5 to 9 days of lens wear
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
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).
After 5 to 9 days of lens wear
Study Arms (2)
Etafilcon A toric contact lens/Nelfilcon A toric
OTHEREtafilcon A toric contact lens first, then nelfilcon A toric second
Nelfilcon A toric/ Etafilcon A toric
OTHERNelfilcon A toric contact lens first, then etafilcon A toric toric second
Interventions
contact lens to correct astigmatism
contact lens to correct astigmatism
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Los Angeles, California, 90049, United States
Unknown Facility
Jacksonville, Florida, 32205, United States
Unknown Facility
Jacksonville, Florida, 32256, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
New York, New York, 10001, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ross Franklin
- Organization
- Johnson & Johnson Vision Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 25, 2010
Study Start
January 1, 2010
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
June 19, 2018
Results First Posted
February 7, 2013
Record last verified: 2015-05