Status:
COMPLETED
Safety and Effectiveness of the Qualis Contact Lens
Lead Sponsor:
Unicon Optical Co. Ltd.
Conditions:
Refractive Errors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.
Detailed Description
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study comparing the Qualis Silicone Hydrogel Soft Contact Lens for Daily Wear with the currently mark...
Eligibility Criteria
Inclusion
- The subject must read, understand, and sign the informed consent form and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be at least 18 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
- The subject's refractive cylinder must be ≤ 0.75 Diopters in each eye.
- The subject must have best corrected visual acuity of 20/25 (LogMAR) or better in each eye.
- Subjects should own a wearable pair of spectacles.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week
Exclusion
- Subjects may not be enrolled into the study if ANY of the following apply:
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- The use of systemic or ocular medications that would contraindicate contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.).
- Any grade 2 or greater slit lamp findings for corneal staining, and any grade 3 or greater slit lamp findings for other abnormalities (e.g., edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) on the ISO 11980 classification scale, any current inflammatory events or events within the last 6 months, or any other ocular abnormality that may contraindicate contact lens wear.
- Any known hypersensitivity or allergic reaction to Biotrue or ClearCare contact lens care solutions
- Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Extended wear, monovision or multi-focal contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Any subject where the randomized lens demonstrates a fit that is deemed inappropriate by the investigator, including, but not limited to, the lens being too flat, too steep, have excessive or inadequate movement, and/or insufficient limbal coverage.
- Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04295499
Start Date
July 1 2020
End Date
January 28 2021
Last Update
October 19 2023
Active Locations (3)
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1
Ala Moana Advanced Eye Clinic
Honolulu, Hawaii, United States, 96814
2
SUNY College of Optometry
New York, New York, United States, 10036
3
The Ohio State University
Columbus, Ohio, United States, 43210