Clinical Evaluation of Approved Contact Lenses

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699593
• Other study ID #: CR-5809
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: May 4, 2016
• Start date: February 2016
• Est. completion date: April 2016

Study information

• Verified date: May 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 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 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 at least 18 and not more than 70 years of age (including 70).

4. The subject's refractive cylinder must be < 0.75 Diopters (D) in each eye.

5. The subject must have best corrected visual acuity of 20/25 or better in each eye.

6. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).

7. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

8. The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.

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 that may interfere with contact lens wear.

4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, 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 known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.

8. Any ocular infection.

9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

10. Monovision or multi-focal contact lens correction.

11. Participation in any contact lens or lens care product clinical trial within 14 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. Suspicion of or recent history of alcohol or substance abuse.

15. History of serious mental illness.

16. History of seizures.

17. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Study Design

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

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Test Contact Lens

• Control Contact Lens

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Eye Elements Eyecare	Jacksonville	Florida
United States	Advantage Eyecare Associates, LLC	Neodesha	Kansas
United States	Advanced Eyecare, PC	Raytown	Missouri
United States	Timothy R. Poling, OD	Roanoke	Virginia
United States	Golden Vision	Sarasota	Florida
United States	Professional Vision Care	Westerville	Ohio

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	Overall comfort score of subjective Contact Lens User Experience® (CLUE®) Questionnaire will show non-inferior in Test versus Control	Comfortable wearing time (average in hours): A non-inferiority lower bound of 1 hour will be used to assess the difference (Test-Control) in comfortable wearing time.	2 weeks for each arm	No
Primary	logMAR Visual Acuity using ETDRS visual acuity charts	The test lens will be non-inferior to the control lens with respect to logMAR visual performance (using ETDRS visual acuity charts) at the follow-up visit. A non-inferiority lower bound of +0.05 will be used to assess the difference (Test-Control) in objective visual performance using ETDRS visual acuity charts.	2 weeks for each arm	No