One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers

NCT ID: NCT02081677

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-06
• Study Completion Date: 2014-06-25

Brief Summary

There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.

Conditions

Visual Correction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

etafilcon A

Marketed control soft contact lens

Group Type: ACTIVE_COMPARATOR

ACUVUE 2

Intervention Type: DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

Prototype E1

Investigational soft contact lens

Group Type: EXPERIMENTAL

Prototype E1

Intervention Type: DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

Prototype E2

Investigational soft contact lens

Group Type: EXPERIMENTAL

Prototype E2

Intervention Type: DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

Prototype E3

Investigational soft contact lens

Group Type: EXPERIMENTAL

Prototype E3

Intervention Type: DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

Interventions

ACUVUE 2

worn in a daily wear modality; lenses will be replaced after 2 weeks

Intervention Type: DEVICE

Prototype E1

worn in a daily wear modality; lenses will be replaced after 2 weeks

Intervention Type: DEVICE

Prototype E2

worn in a daily wear modality; lenses will be replaced after 2 weeks

Intervention Type: DEVICE

Prototype E3

worn in a daily wear modality; lenses will be replaced after 2 weeks

Intervention Type: DEVICE

Other Intervention Names

Investigational soft contact lens; Investigational soft contact lens; Investigational soft contact lens

Eligibility Criteria

Inclusion Criteria

1. The subject must be between 18 and 39 years of age.

2. The subject must be able to read and understand English.

3. The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

4. The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.

5. The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).

6. The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.

7. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.

8. The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.

9. The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.

10. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

11. The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

• No amblyopia
• No evidence of lid abnormality or infection (including blepharitis/meibomitis)
• No conjunctival abnormality or infection.
• No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities).
• No other active ocular diseases.

Exclusion Criteria

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

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

3. Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

4. Any ocular infection.

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

6. Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).

7. No extended wear in the last 3 months.

8. Diabetes.

9. Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).

10. Has had refractive surgery.

11. Employee of VRF with direct involvement in the study or a family member of the clinic.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chennai, Tamil Nadu, India

Countries

India

Other Identifiers

CR-5146

Identifier Type: -

Identifier Source: org_study_id