- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537522
Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
June 14, 2017 updated by: Johnson & Johnson Vision Care, Inc.
The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Jacksonville, Florida, United States, 32205
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Jacksonville, Florida, United States, 32256
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
- The subject must be willing and able to adhere to the instructions set out in the protocol.
- The subject must be an adapted soft contact lens wearer in both eyes.
- The subject must be willing to wear the study contact lenses up to 14 hours/day.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
- The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
- 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 (i.e., no ocular medications or infections of any type).
Exclusion Criteria:
- Current 1-DAY ACUVUE® TruEye® wearers
- Anisometropia of 1.00 D or greater
- Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- Any Systemic disease, autoimmune disease, or use of medication which might 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
- Diabetes
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test/Control - Phase 1
Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner.
|
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
|
Experimental: Control/Test - Phase 1
Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner.
|
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
|
Experimental: Test/Control - Phase 2
During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner.
|
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
|
Experimental: Control/Test - Phase 2
During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner.
|
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation Between Subjective CLUE Comfort and Keratometry
Time Frame: 3-day follow-up
|
CLUE- The Contact Lens User Evaluation (CLUE)™ 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.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ.
Et al. August 2016).
Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes.
The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.
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3-day follow-up
|
Correlation Between Subjective CLUE Comfort and Corneal Diameter
Time Frame: 3-day follow-up
|
Assessment The Contact Lens User Evaluation (CLUE)™ 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.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016).
Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.
|
3-day follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
August 28, 2015
First Submitted That Met QC Criteria
August 31, 2015
First Posted (Estimate)
September 1, 2015
Study Record Updates
Last Update Posted (Actual)
July 11, 2017
Last Update Submitted That Met QC Criteria
June 14, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CR-5730
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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