CompletedInterventionalNot ApplicableUpdated May 9, 2023
Clinical Performance Evaluation of Two Silicone Hydrogel Lenses | NCT02756078 | Trialant
CompletedInterventionalNot ApplicableUpdated Nov 14, 2018
Clinical Performance Evaluation of Two Silicone Hydrogel Lenses
ClinicalTrials.gov ID
NCT02756078
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
200Actual
Last Update Posted
Nov 14, 2018Actual
Start Date
Apr 8, 2016Actual
Primary Completion Date
Oct 2, 2017Actual
Completion Date
Oct 2, 2017Actual
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.
Visual Acuity
TEST Contact Lens
CONTROL Contact Lens
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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 Purpose
Treatment
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
No central contacts
There are no central contacts for this study.
Centre for Contact Lens Research, University of Waterloo