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NCT01120782 Clinical Trial

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

Astigmatism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01120782
Other study ID # CR-1476AI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2010
Est. completion date February 1, 2010

Study information
Verified date September 2017
Source Johnson & Johnson Vision Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date February 1, 2010
Est. primary completion date February 1, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• etafilcon A toric contact lens with new wetting agent
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
• etafilcon A toric contact lens
Marketed toric contact lens made of etafilcon A material.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prescription Equivalence Number of subjects whose prescription is the same for the two lenses tested. after 15 minutes of lens wear
See also
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Completed NCT02624791 - Evaluating and Improving Functional Driving Vision of Patients With Astigmatism N/A
Completed NCT01211535 - Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers N/A