Clinical trial NCT02427477: A Comparison of Two Daily Disposable Soft 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: 2015-04-28
Enrollment: 120
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: Approximately 120 subjects will be comparing two soft contact lenses for one week each.


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 be appear able and willing to adhere to instruction set forth in this clinical protocol.
3. The subject 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. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
6. 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 any medication, which may interfere with contact lens wear.
4. Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, PRK, 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 inflammatory event (e.g. past peripheral ulcer or round 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, multifocal, 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.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.

Primary outcomes:
measure: Subjective Overall Comfort
timeFrame: 1-week Follow-up
measure: Subjective Overall Vision
timeFrame: 1-week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Jacksonville Beach
country: United States
state: Florida
city: Longwood
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Westerville
country: United States
state: Ohio
city: Salem
country: United States
state: Virginia
Study officials:
References: