Status:
COMPLETED
Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.
Eligibility Criteria
Inclusion
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Subjects must be 18-69 years of age (inclusive).
- Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
- Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
- The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
- The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
- Subjects must read, understand, and sign the Statement of Informed Consent.
- Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or breast-feeding.
- Diabetes
- Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
- Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
- Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
- Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
- Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
- Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
- Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
- Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
- History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
- Habitual contact lens wear modality as extended wear.
- Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Habitual wearers of rigid gas permeable lens within the past 3 months.
- Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2018
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03466060
Start Date
February 7 2018
End Date
June 19 2018
Last Update
October 2 2019
Active Locations (5)
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1
Southern California College of Optometry
Anaheim, California, United States, 92807
2
University of California, Berkeley School of Optometry
Berkeley, California, United States, 94720
3
Vue Optical Boutique
Jacksonville, Florida, United States, 32205
4
The Ohio State University
Columbus, Ohio, United States, 43210