Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
Status
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Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
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Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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Subjects must be 18-69 years of age (inclusive).
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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.
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Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
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The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
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The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
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The subject must have normal eyes (i.e., no ocular medications or infections of any type).
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Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
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Subjects must read, understand, and sign the Statement of Informed Consent.
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Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria:
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
130 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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