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

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etafilcon A toric contact lens with new wetting agent
etafilcon A toric contact lens
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

etafilcon A toric new lens/etafilcon A toric lens

etafilcon A toric lens/etafilcon A toric new lens

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prescription Equivalence
Number of subjects whose prescription is the same for the two lenses tested.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01120782
Brief Title
Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2010 (Actual)
Primary Completion Date
February 1, 2010 (Actual)
Study Completion Date
February 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A toric new lens/etafilcon A toric lens
Arm Type
Active Comparator
Arm Description
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.
Arm Title
etafilcon A toric lens/etafilcon A toric new lens
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
etafilcon A toric contact lens with new wetting agent
Intervention Description
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
Intervention Type
Device
Intervention Name(s)
etafilcon A toric contact lens
Intervention Description
Marketed toric contact lens made of etafilcon A material.
Primary Outcome Measure Information:
Title
Prescription Equivalence
Description
Number of subjects whose prescription is the same for the two lenses tested.
Time Frame
after 15 minutes of lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must be between 18 and 40 years old. The subject must have normal eyes. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye. The subject's refractive cylinder axis must be 180 +/- 30 in each eye. The subject must be an adapted wearer of soft toric contact lenses in both eyes. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye. Subjects must already possess a wearable pair of spectacles. - Exclusion Criteria: Ocular or systemic allergies or disease that may interfere with contact lens wear. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. Clinically significant tarsal abnormalities that might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). Diabetes Strabismus -
Facility Information:
City
Jacksonville
State/Province
Florida
Country
United States
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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