NCT01120782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 8, 2011

Completed
Last Updated

June 19, 2018

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

May 4, 2010

Results QC Date

November 4, 2011

Last Update Submit

June 18, 2018

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Prescription Equivalence

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

    after 15 minutes of lens wear

Study Arms (2)

etafilcon A toric new lens/etafilcon A toric lens

ACTIVE COMPARATOR

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 agentDevice: etafilcon A toric contact lens

etafilcon A toric lens/etafilcon A toric new lens

ACTIVE COMPARATOR

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 agentDevice: etafilcon A toric contact lens

Interventions

etafilcon A toric contact lens with new wetting agentDEVICE

Investigational toric contact lens made of etafilcon A material with a new wetting agent.

etafilcon A toric lens/etafilcon A toric new lensetafilcon A toric new lens/etafilcon A toric lens
etafilcon A toric contact lensDEVICE

Marketed toric contact lens made of etafilcon A material.

etafilcon A toric lens/etafilcon A toric new lensetafilcon A toric new lens/etafilcon A toric lens

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

New York, New York, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Ross Franklin, OD
Organization
Johnson & Johnson Vision Care
RFrankl1@its.jnj.com
1-904-443-1379

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 11, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 19, 2018

Results First Posted

December 8, 2011

Record last verified: 2017-09

Locations

US(2)