Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types

NCT ID: NCT01120782

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-01
• Study Completion Date: 2010-02-01

Brief Summary

The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.

Conditions

Astigmatism

Study Design

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

Study Groups

etafilcon A toric new lens/etafilcon A toric lens

The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.

Group Type: ACTIVE_COMPARATOR

etafilcon A toric contact lens with new wetting agent

Intervention Type: DEVICE

Investigational toric contact lens made of etafilcon A material with a new wetting agent.

etafilcon A toric contact lens

Intervention Type: DEVICE

Marketed toric contact lens made of etafilcon A material.

etafilcon A toric lens/etafilcon A toric new lens

The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.

Group Type: ACTIVE_COMPARATOR

etafilcon A toric contact lens with new wetting agent

Intervention Type: DEVICE

Investigational toric contact lens made of etafilcon A material with a new wetting agent.

etafilcon A toric contact lens

Intervention Type: DEVICE

Marketed toric contact lens made of etafilcon A material.

Interventions

etafilcon A toric contact lens with new wetting agent

Investigational toric contact lens made of etafilcon A material with a new wetting agent.

Intervention Type: DEVICE

etafilcon A toric contact lens

Marketed toric contact lens made of etafilcon A material.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject must be between 18 and 40 years old.

2. The subject must have normal eyes.

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

4. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

5. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.

6. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.

7. The subject's refractive cylinder axis must be 180 +/- 30 in each eye.

8. The subject must be an adapted wearer of soft toric contact lenses in both eyes.

9. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.

10. Subjects must already possess a wearable pair of spectacles. -

Exclusion Criteria

1. Ocular or systemic allergies or disease that may interfere with contact lens wear.

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

3. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.

4. Clinically significant tarsal abnormalities that might interfere with contact lens wear.

5. Any ocular infection.

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

7. Pregnancy or lactation

8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

9. Diabetes

10. Strabismus -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jacksonville, Florida, United States

New York, New York, United States

Countries

United States

Other Identifiers

CR-1476AI

Identifier Type: -

Identifier Source: org_study_id