Clinical trial NCT02568254: Evaluation of Three Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing 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 willing and able to follow instructions and maintain the appointment schedule;
* The subject must be between the age of 18 and 40 years (inclusive);
* The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive);
* The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane;
* The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye;
* The subject must be a current wearer of spherical, soft contact lenses (no toric, 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 own a wearable pair of spectacles and wear them the day of the initial visit;
* The subject must be an existing wearer of spherical, soft contact lenses in both eyes;
* The subject must have normal eyes (i.e., no ocular medications or infections of any type);
* The subject must be willing to wear the study lenses for a minimum eight hours per day.

Exclusion Criteria:

* 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);
* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued);
* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease;
* Any active ocular infection;
* Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit;
* Any participants whose habitual contact lenses are used as an extended wear regimen;
* 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-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; or 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;
* Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

Primary outcomes:
measure: Overall Comfort
timeFrame: 2- Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
References: