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

Sponsor
Johnson & Johnson Vision Care, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01120782
Collaborator
(none)
45
Enrollment
2
Locations
2
Arms
22.5
Patients Per Site

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: etafilcon A toric contact lens with new wetting agent
  • Device: etafilcon A toric contact lens
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Actual Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Prescription Equivalence [after 15 minutes of lens wear]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 -

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1JacksonvilleFloridaUnited States
2New YorkNew YorkUnited States

Sponsors and Collaborators

  • Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01120782
Other Study ID Numbers:
  • CR-1476AI
First Posted:
May 11, 2010
Last Update Posted:
Jun 19, 2018
Last Verified:
Sep 1, 2017
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailDue to test article shipment error, one clinical site did not receive control test article in a required cylinder and all screened/enrolled subject were unable to be fitted according to the protocol and were discontinued.
Arm/Group TitleAll Subjects
Arm/Group DescriptionAll subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Period Title: Overall Study
STARTED45
COMPLETED34
NOT COMPLETED11

Baseline Characteristics

Arm/Group TitleAll Subjects
Arm/Group DescriptionAll subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Overall Participants45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
29.2
(5.10)
Sex: Female, Male (Count of Participants)
Female
13
28.9%
Male
32
71.1%
Region of Enrollment (participants) [Number]
United States
45
100%

Outcome Measures

1. Primary Outcome
TitlePrescription Equivalence
DescriptionNumber of subjects whose prescription is the same for the two lenses tested.
Time Frameafter 15 minutes of lens wear

Outcome Measure Data

Analysis Population Description
All completed subjects.
Arm/Group TitleAll Subjects
Arm/Group DescriptionAll subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Measure Participants34
Number [participants]
34
75.6%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleAll Subjects
Arm/Group DescriptionAll subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
All Cause Mortality
All Subjects
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
All Subjects
Affected / at Risk (%)# Events
Total0/45 (0%)
Other (Not Including Serious) Adverse Events
All Subjects
Affected / at Risk (%)# Events
Total0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication requires agreement and written authorization from Sponsor.

Results Point of Contact

Name/TitleRoss Franklin, OD
OrganizationJohnson & Johnson Vision Care
Phone1-904-443-1379
EmailRFrankl1@its.jnj.com
Responsible Party:
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01120782
Other Study ID Numbers:
  • CR-1476AI
First Posted:
May 11, 2010
Last Update Posted:
Jun 19, 2018
Last Verified:
Sep 1, 2017