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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02699593
Other study ID # CR-5809
Secondary ID
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


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
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