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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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Page 1 of 1 (3 locations)

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