Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses

Visual Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625233
• Other study ID #: CR-5788
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: April 29, 2016
• Start date: October 2015
• Est. completion date: February 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, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control). Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

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 at least 18 years of age.

• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.

• The subject's refractive cylinder must be = 1.00 Diopters (D) in each eye.

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

• The subject should own a wearable pair of spectacles and bring to initial visit.

• The subject must be an adapted frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.

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

• The subject must have enrolled and completed all visits in clinical study CR-5726.

Exclusion Criteria:

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

• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).

• Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g., Accutane), oral tetracyclines, topical scopolamine, oral phenothiazines (e.g. Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or OTC ocular medication.

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

• 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 known hypersensitivity or allergic reaction to Opti-Free® PureMoist® multipurpose care solution or Eye-Cept rewetting drop solution

• Any ocular infection, allergy or clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.

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

• Daily disposables, extended wear, monovision or multi-focal contact lens correction.

• History of binocular vision abnormality or strabismus.

• Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)

Study Design

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

Related Conditions & MeSH terms

• Vision Disorders
• Visual Disorders

Intervention

Device:
• senofilcon C

• comfilcon A

Locations

Country	Name	City	State
United States	Eyecare Associates	Bloomington	Illinois
United States	Dr. Debbie H. Kim, OD	Closter	New Jersey
United States	Vue Optical Boutique	Jacksonville	Florida
United States	Omega Vision Center, PA / Sabal Eye Care	Longwood	Florida
United States	Dr. William Bogus	Salt Lake City	Utah
United States	Sacco Eye Group	Vestal	New York

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	The proportion of eyes with FDA Grading Scales Slit Lamp Findings Grade 3 or higher	Slit Lamp finding will be assessed using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements include edema, corneal neovascularization, corneal staining, injection, tarsal abnormalities and other complications	Throughout the duration of the study up to 6 Month	Yes
Primary	Visual Acuity	Visual Acuity Measured by logMar via Early Testing Diabetic Retinopathy Study.	Throughout the duration of the study up to 6 Month	No