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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: etafilcon A toric contact lens with new wetting agent; Device: etafilcon A toric contact lens

• Registration Number: NCT01120782
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Primary Completion: 2010-02-01
• Study Completion: 2010-02-01
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-11
• Results First Submitted: 2011-11-04
• Results First Submitted QC: 2011-11-04
• Results First Posted: 2011-12-08
• Status Verified: 2017-09
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
etafilcon A toric new lens/etafilcon A toric lens	etafilcon A toric contact 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.
etafilcon A toric lens/etafilcon A toric new lens	etafilcon A toric contact lens with new wetting agent	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.
etafilcon A toric new lens/etafilcon A toric lens	etafilcon A toric contact lens with new wetting agent	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.
etafilcon A toric lens/etafilcon A toric new lens	etafilcon A toric contact 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.

Primary Outcome Measures

Name	Time	Method
Prescription Equivalence	after 15 minutes of lens wear	Number of subjects whose prescription is the same for the two lenses tested.