Clinical trial NCT02669095: Clinical Evaluation of Approved and Investigational Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Disorder
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.


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 to 40 years of age at the time of consent.
* The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.
* Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.
* The subject must have best corrected visual acuity of 20/30 or better in each eye.
* The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
* The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.
* The subject must have normal eyes (i.e., no ocular medications or infections of any type).

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.
* Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
* Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
* 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.).
* Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Primary outcomes:
measure: Acceptable Lens Fitting
timeFrame: Up to 4 Week Follow-up
measure: Overall Comfort
timeFrame: Up to 4 Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Golden Family Eyecare
state: Florida
city: Winter Park
country: United States
facility: Eye Associates of Winter Park
state: Florida
city: Pickens
country: United States
facility: Pickens Family Eye Care
state: South Carolina
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
Study officials:
References: