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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: etafilcon A toric contact lens with new wetting agent; Device: etafilcon A toric contact lens

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States
  • New York
    • New York, New York, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: etafilcon A toric contact lens with new wetting agent; Investigational toric contact lens made of etafilcon A material with a new wetting agent.; Device: etafilcon A toric contact lens; Marketed toric contact lens made of etafilcon A material.
Active Comparator: 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.	Device: etafilcon A toric contact lens with new wetting agent; Investigational toric contact lens made of etafilcon A material with a new wetting agent.; Device: etafilcon A toric contact lens; Marketed toric contact lens made of etafilcon A material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription Equivalence	Number of subjects whose prescription is the same for the two lenses tested.	after 15 minutes of lens wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (Estimate): May 11, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-1476AI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes