Refractive Errors
Conditions
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 marketed Acuvue Vita (senofilcon C) Monthly Contact Lens (FDA cleared under K160212). Eligible subjects will be examined for baseline evaluation and lens fitting. Up to fifty (50) subjects will wear the test contact lenses and up to twenty-five (25) subjects will wear the control contact lenses. The subjects will undergo standard ophthalmic evaluation for contact lens wear and will be followed for a period of at least ninety (91) days.
Interventions
DEVICEsoft (hydrophilic) contact lens
The intervention is a daily wear soft contact lens
Sponsors
Unicon Optical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Non-Serious Adverse Reactions | 91 days | The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations. |
| Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | 91 days | The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better |
Countries
United States
Participant flow
Recruitment details
The enrollment period started in July 2020 and was closed in October 2020 after successfully fulfilling the enrollment goal (75 subjects). Data collection occurred from July 22, 2020 to January 28, 2021.
Participants by arm
| Arm | Count |
|---|---|
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA.
soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens | 50 |
| Control Device: Acuvue Vita Monthly Contact Lens Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA.
soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | moving out of state | 1 | 0 |
| Overall Study | traveling overseas for business prior to the study completion | 1 | 0 |
Baseline characteristics
| Characteristic | Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Total | Control Device: Acuvue Vita Monthly Contact Lens |
|---|---|---|---|
| Age, Continuous | 26.90 years | 27.04 years | 27.32 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 30 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 41 Participants | 14 Participants |
| Region of Enrollment United States | 50 participants | 75 participants | 25 participants |
| Sex: Female, Male Female | 33 Participants | 50 Participants | 17 Participants |
| Sex: Female, Male Male | 17 Participants | 25 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 25 |
| other Total, other adverse events | 6 / 50 | 3 / 25 |
| serious Total, serious adverse events | 0 / 50 | 0 / 25 |
Outcome results
Primary
Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better
The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better
Time frame: 91 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | Initial best corrected contact lens visual acuity with spherical over-refraction | 100 eyes |
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | Visual acuity (VA) results -Day91- | 96 eyes |
| Control Device: Acuvue Vita Monthly Contact Lens | Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | Visual acuity (VA) results -Day91- | 47 eyes |
| Control Device: Acuvue Vita Monthly Contact Lens | Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | Initial best corrected contact lens visual acuity with spherical over-refraction | 50 eyes |
Primary
Number of Eyes With Non-Serious Adverse Reactions
The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.
Time frame: 91 days
Population: open-label, multi-center, randomized concurrent-control study with the treatment duration of 91 days.~Seventy-five (75) subjects were enrolled in the study-of which 50 subjects wore the test lenses (Qualis (Linofilcon A) Silicone Hydrogel Soft Contact Lens for Daily Wear) and 25 subjects wore the control lenses (Acuvue Vita (senofilcon C) Monthly Contact Lens).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Number of Eyes With Non-Serious Adverse Reactions | Non-ocular adverse events (significant but non-serious) | 1 eyes |
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Number of Eyes With Non-Serious Adverse Reactions | Non-device related ocular adverse events (significant but non-serious) | 7 eyes |
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Number of Eyes With Non-Serious Adverse Reactions | Device related ocular adverse events (significant but non-serious) | 1 eyes |
| Control Device: Acuvue Vita Monthly Contact Lens | Number of Eyes With Non-Serious Adverse Reactions | Non-ocular adverse events (significant but non-serious) | 3 eyes |
| Control Device: Acuvue Vita Monthly Contact Lens | Number of Eyes With Non-Serious Adverse Reactions | Non-device related ocular adverse events (significant but non-serious) | 0 eyes |
| Control Device: Acuvue Vita Monthly Contact Lens | Number of Eyes With Non-Serious Adverse Reactions | Device related ocular adverse events (significant but non-serious) | 1 eyes |