Clinical trial NCT02756078: Clinical Performance Evaluation of Two Silicone Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.


Eligibility criteria: Inclusion Criteria:

* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT 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 between 18 and 40 years of age.
* The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye.
* The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane.
* The subject must have best corrected visual acuity of 0.20 or better in each eye.
* The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
* The subject must be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day.
* The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.
* The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
* The subject must meet normal eligibility conditions of binocular vision tests.
* The subject may not have any double vision at near with their habitual contact lens correction.

Exclusion Criteria:

* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
* Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion).
* Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
* Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion).
* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
* Any active ocular infection.
* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
* Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any known hypersensitivity or allergic reaction to the study products.
* Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
* History of binocular vision abnormality or strabismus.
* Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Primary outcomes:
measure: Overall CLUE Comfort
timeFrame: Up to 4-Week Follow-up
Secondary outcomes:
measure: Overall CLUE Handling
timeFrame: Up to 4-Week Follow-up
measure: Time to Haze
timeFrame: Up to 4-Week Follow-up
measure: Average Wear Time
timeFrame: Up to 4-Week Follow-up
measure: Average Comfortable Wear Time
timeFrame: Up to 4-Week Follow-up
measure: Difference in Total Device Use Time and Comfortable Wear Time During Device Use
timeFrame: Up to 4-Week Follow-up
measure: Comfort at the End of the Day
timeFrame: Up to 4-Week Follow-up
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
References: