Clinical Evaluation of Fitting Investigational Contact Lenses

NCT ID: NCT03150485

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2017-03-31

Brief Summary

This study is a non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.

Conditions

Visual Acuity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

etafilcon A Toric Multifocal

Group Type: EXPERIMENTAL

JJVC Fitting Guides

Intervention Type: DEVICE

Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.

etafilcon A Multifocal

Group Type: ACTIVE_COMPARATOR

JJVC Fitting Guides

Intervention Type: DEVICE

Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.

Interventions

JJVC Fitting Guides

Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.

Intervention Type: DEVICE

Eligibility Criteria

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. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.

4. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

5. The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).

6. The subject's distance spherical equivalent or spherical component (if fit with a toric lens) of their refraction must be in the range -1.25 D to -3.75 D in each eye.

7. The subject's refractive cylinder must be 0.00 D to -1.50 D in at least one eye and no greater than -1.50 D in either eye.

8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.

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

10. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.

11. The subject must have a wearable pair of spectacles if required for their distance vision.

Exclusion Criteria

1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.

2. Pregnancy or lactation.

3. Currently diagnosed with diabetes.

4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).

5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.

6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.

7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).

8. A history of amblyopia, strabismus or binocular vision abnormality.

9. Any ocular infection or inflammation.

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

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

12. History of herpetic keratitis.

13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vistakon Research Clinic

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-5913

Identifier Type: -

Identifier Source: org_study_id