Status:
COMPLETED
Evaluation of Prototype Lenses With Experimental UV/HEV Blocker
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.
Eligibility Criteria
Inclusion
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be between 18 and 39 (inclusive) years of age at the time of screening.
- By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
- Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (except -5.00 D) in both eyes.
- The subject's refractive cylinder must be 1.00 D or less.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
- Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear modality.
- Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Have a history of binocular vision abnormality or strabismus.
- Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
- Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Have any ocular infection.
- Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2021
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04885296
Start Date
May 10 2021
End Date
August 9 2021
Last Update
September 1 2022
Active Locations (12)
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1
Dr. James Weber & Associates, PA
Jacksonville, Florida, United States, 32205
2
Flora Chen Poveda, OD, PA
Orange Park, Florida, United States, 32073
3
Tallahassee Eye Center
Tallahassee, Florida, United States, 32308
4
Visual Eyes
Roswell, Georgia, United States, 30075