Handling Comparison Between Two Contact Lens Types

NCT ID: NCT02310126

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2014-12-01

Brief Summary

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

etafilcon A(sphere)/etafilcon A(multi-focal)

Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.

Group Type: ACTIVE_COMPARATOR

etafilcon A (multi-focal)

Intervention Type: DEVICE

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

etafilcon A (sphere)

Intervention Type: DEVICE

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

etafilcon A(multi-focal)/etafilcon A(sphere)

Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.

Group Type: ACTIVE_COMPARATOR

etafilcon A (multi-focal)

Intervention Type: DEVICE

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

etafilcon A (sphere)

Intervention Type: DEVICE

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

Interventions

etafilcon A (multi-focal)

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

Intervention Type: DEVICE

etafilcon A (sphere)

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

Intervention Type: DEVICE

Other Intervention Names

Investigational Multifocal Contact; 1-DAY ACUVUE® MOIST®

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. The subject must be between 40 and 70 years of age.

4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.

5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.

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

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

8. Subject must own a wearable pair of spectacles.

9. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)

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

Exclusion Criteria

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

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

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

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

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

6. Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

7. Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.

8. Any ocular infection or inflammation.

9. History of herpetic keratitis.

10. Any corneal distortion or irregular cornea.

11. History of binocular vision abnormality or strabismus.

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

13. Current history of diabetes.

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

• 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

Baymeadows Vision Center

Jacksonville, Florida, United States

Eye Elements Eyecare

Jacksonville, Florida, United States

Vistakon Research Clinic

Jacksonville, Florida, United States

Golden Family Eyecare

Sarasota, Florida, United States

Eye Associates of Winter Park

Winter Park, Florida, United States

Central Ohio Eyecare

Columbus, Ohio, United States

Optometry Group LLC

Memphis, Tennessee, United States

Nashville Vision Associates

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

CR-5570

Identifier Type: -

Identifier Source: org_study_id