Clinical trial NCT02759692: Clinical Evaluation of Two Approved 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: 2016-05-03
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.


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 (and including) 18 and 39 years of age.
4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study.
5. Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
6. Have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
7. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or breastfeeding (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 autoimmune disease or use of medication, which may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
6. 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.
7. Any ocular infection.
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Monovision, multi-focal, toric, or extended wear contact lens correction.
10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
11. History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
12. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

Primary outcomes:
measure: Overall Comfort
timeFrame: 7-Day Follow-up
measure: Overall Quality of Vision
timeFrame: 7-Day Follow-up
Secondary outcomes:
measure: Individual Patient Reported Outcomes (Items 1-5)
timeFrame: 7-Day Follow-up
measure: Individual Patient Reported Outcomes (Items 6-10)
timeFrame: 7-Day Follow-up
measure: Individual Patient Reported Outcomes (Items 11-14)
timeFrame: 7-Day Follow-up
measure: Individual Patient Reported Outcomes (Items 15-17)
timeFrame: 7-Day Follow-up
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Becky Bizzle, OD
state: Alabama
city: Jacksonville
country: United States
facility: Complete Family Eye Care of Fruit Cove
state: Florida
city: Sarasota
country: United States
facility: Golden Family Eyecare
state: Florida
city: Tampa
country: United States
facility: St. Lucy's Vision Center
state: Florida
city: Winter Park
country: United States
facility: Eye Associates of Winter Park
state: Florida
city: Roswell
country: United States
facility: VisualEyes, Inc.
state: Georgia
city: Neodesha
country: United States
facility: Advantage Eyecare Associates, LLC
state: Kansas
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Denver
country: United States
facility: Advanced Family Eye Care
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
city: Jacksonville
country: United States
facility: Brian Frazier, OD
state: Texas
city: Salem
country: United States
facility: Timothy R. Poling, OD
state: Virginia
city: West Allis
country: United States
facility: Ziegler Leffingwell Eyecare
state: Wisconsin
Study officials:
References: