Clinical Study of Approved and Investigational Contact Lenses

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708524
• Other study ID #: CR-5808
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: April 29, 2016
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Senofilcon C Contact Lens

• Comfilcon A Contact Lens

• Lotrafilcon B Contact Lens

• Samfilcon A Contact Lens

Locations

Country	Name	City	State
United States	Eyecare Associates	Bloomington	Illinois
United States	VisionCare Associates	East Lansing	Michigan
United States	Complete Family Eye Care of Fruit Cove	Fruit Cove	Florida
United States	ProCare Vision Centers	Granville	Ohio
United States	Brian Frazier, OD	Jacksonville	Texas
United States	Vue Optical Boutique	Jacksonville	Florida
United States	Omega Vision Center, PA / Sabal Eye Care	Longwood	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Becky Bizzle, OD	Montgomery	Alabama
United States	Timothy R. Poling, OD	Roanoke	Virginia
United States	Dr. William Bogus	Salt Lake City	Utah
United States	St. Lucy's Vision Center	Tampa	Florida
United States	Sacco Eye Group	Vestal	New York
United States	Ziegler Leffingwell Eyecare	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Assessments of Overall Contact Lens User Experience (CLUE®) Questionnaire Scores on Comfort	Contact lens comfort will be evaluated when worn for 30 (-2/+6) days on daily wear modality using the CLUE® Questionnaire, a validated patient-reported outcomes questionnaire used to assess patient-experience attributes of soft contact lenses.	5 visits over a 30 (-2/+6)-day period	No