Clinical Evaluation of Approved and Investigational Contact Lenses

Visual Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669095
• Other study ID #: CR-5796
• Status: Completed
• Phase: N/A
• First received: January 27, 2016
• Last updated: June 13, 2016
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• 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:

• 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 18 to 40 years of age at the time of consent.

• The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.

• Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.

• The subject must have best corrected visual acuity of 20/30 or better in each eye.

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

• The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.

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

Exclusion Criteria:

• Currently pregnant or lactating (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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

• Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.

• 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 ocular infection.

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

• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Study Design

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

Related Conditions & MeSH terms

• Vision Disorders
• Visual Disorder

Intervention

Device:
• Investigational Contact Lenses (Test)

• Marketed Contact Lenses (Control)

Locations

Country	Name	City	State
United States	Total Eye Care PA	Memphis	Tennessee
United States	Pickens Family Eye Care	Pickens	South Carolina
United States	Golden Family Eyecare	Sarasota	Florida
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	Subjective Assessment of Overall Contact Lens User Experience™ (CLUE) Questionnaire Comfort Across all Follow-Up Visits	Subjective assessment of comfort will be performed using the CLUE™ Questionnaire.	30 (-2/+6) days on daily wear modality	No
Secondary	Proportion of Eyes With Acceptable Lens Fitting Across All Follow-Up Visits		30 (-2/+6) days on daily wear modality	No