Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses

Vision Disorders Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02595502
• Other study ID #: CR-5743
• Status: Active, not recruiting
• Phase: N/A
• First received: November 2, 2015
• Last updated: November 19, 2015
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• 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

The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

• The subject must be between (and including) 18 and 39 years of age.

• 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.

• The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye.

• The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.

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

Exclusion Criteria:

• Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).

• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

• Any autoimmune disease or use of medication, which may interfere with contact lens wear.

• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).

• 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.

• Any ocular infection.

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

• Monovision, multi-focal, toric, or extended wear contact lens correction.

• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

• History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.

• Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vision Disorders

Intervention

Device:
• Vistakon Marketed Contact Lens (Test)

• Competitor Marketed Contact Lens (Control)

Locations

Country	Name	City	State
United States	Advanced Family Eye Care	Denver	North Carolina
United States	Complete Family Eye Care of Fruit Cove	Fruit Cove	Florida
United States	Brian Frazier, OD	Jacksonville	Texas
United States	total Eye Care PA	Memphis	Tennessee
United States	Becky Bizzle, OD	Montgomery	Alabama
United States	Advantage Eyecare Associates, LLC	Neodesha	Kansas
United States	Timothy R. Poling, OD	Roanoke	Virginia
United States	VisualEyes, Inc.	Roswell	Georgia
United States	Golden Family Eyecare	Sarasota	Florida
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
United States	Eye Associates of Winter Park	Winter Park	Florida

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	The overall comfort of the test lens will be non-inferior to the control lens at the 1-week follow-up evaluation. This will be measured using the Contact Lens User Experience (CLUE) composite score with an inferiority margin of -5 points.	1 Week	No
Secondary	Overall comfort	The overall comfort of the test lens will be non-inferior to the control lens at the 2 and 3 week follow-up evaluation. This will be measured using the CLUE composite score with an inferiority margin of -5 points.	Week 2 and Week 3	No