Clinical trial NCT02708524: Clinical Study of Approved and Investigational 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: 2016-03-15
Enrollment: 554
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 is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.


Eligibility criteria: Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 18 to 40 years of age at the time of consent.
4. The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
5. The subject's refractive cylinder must be ≤1.00D in each eye.
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
8. The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
9. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
5. Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
8. 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.
9. Any ocular infection.
10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
12. History of binocular vision abnormality or strabismus.
13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
14. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Primary outcomes:
measure: Subjective Overall Comfort Composite Score
timeFrame: Up to 1 month Follow-up
measure: Overall Comfort Individual Item
timeFrame: 1 month follow-up
measure: Comfort at the End of the Day Individual Item
timeFrame: 1 month Follow-up
measure: Comfort Each and Everyday Individual Item
timeFrame: 1 month Follow-up
measure: Frequency of Lens Awareness Individual Item
timeFrame: 1 month Follow-up
measure: Frequency of Experiencing Dryness Individual Item
timeFrame: 1 month Follow-up
measure: Making Your Eyes Feel Moist Throughout the Day Individual Item
timeFrame: Up to 1 month Follow-up
Secondary outcomes:
measure: Subjective Overall Quality of Vision Composite Score
timeFrame: Up to 1 month Follow-up
measure: Overall Quality of Vision Individual Item
timeFrame: Up to 1 month Follow-up
measure: Overall Opinion Individual Item
timeFrame: Up to 1 month Follow-up
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Fruit Cove
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Longwood
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Bloomington
country: United States
state: Illinois
city: East Lansing
country: United States
state: Michigan
city: Medina
country: United States
state: Minnesota
city: Closter
country: United States
state: New Jersey
city: Vestal
country: United States
state: New York
city: Granville
country: United States
state: Ohio
city: Jacksonville
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Roanoke
country: United States
state: Virginia
city: West Allis
country: United States
state: Wisconsin
Study officials:
References: