Marketed Contact Lens Real World Through Focus Curve

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679976
• Other study ID #: CR-5728
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: February 8, 2016
• Start date: July 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 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 =40 years of age.

• The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00D and +4.00D in each eye.

• The subject's refractive cylinder must be = -0.75D in each eye.

• The subject's ADD power must be in the range of +0.75 to +2.50D in each eye.

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

• The subject can be either a new contact lens wearer or an existing soft contact lens wearer.

Exclusion Criteria:

• Currently pregnant or lactating.

• Any ocular or systemic allergies that contraindicate contact lens wear.

• Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear.

• Any ocular abnormality that may interfere with contact lens wear.

• Use of any ocular medication, with the exception of rewetting drops.

• Any previous intraocular 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, and conjunctival injection) which may contraindicate contact lens wear.

• History of herpetic keratitis.

• Any ocular infection or inflammation.

• Any corneal distortion or irregular cornea.

• History of binocular vision abnormality or strabismus.

• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).

• History of diabetes.

• Participant in unrelated research involving test product within 30 days before planned study visit.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• etafilcon A
Marketed Multifocal Contact Lens

Locations

Country	Name	City	State
United Kingdom	Otometry Technology Group, Ltd.	London

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular TFC Visual Acuity (high luminance/high contrast or overall)		Visit 1, after 4-hour lens settling period	No