Safety and Effectiveness of the Qualis Contact Lens

Completed · Not applicable

Conditions studied: Refractive Errors

In brief

Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.

Key facts

Study ID

NCT04295499

Run by

Unicon Optical Co. Ltd.

People needed

75

Starts

2020-07-01

Expected to finish

2021-01-28

Last updated by the study team

2023-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Ala Moana Advanced Eye Clinic — Honolulu, Hawaii, United States
• SUNY College of Optometry — New York, New York, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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