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Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

senofilcon A toric contact lens

balafilcon A toric contact lens

About this trial

This is an interventional other trial for Astigmatism

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Able to wear study lenses in parameters available
Non-presbyopes between the ages of 18-45
Understand and sign informed consent
Willing to follow the protocol
Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
Adapted soft contact lens wearer
Swims no more than once a week
Has a wearable pair of spectacles.

Exclusion Criteria:

Any ocular or systemic disorder which may contraindicate contact lens wear
Any topical ocular medication
Aphakic
Corneal refractive surgery
Corneal distortion from hard CL wear or keratoconus
Pregnant or lactating
Grade 2 or worse slit lamp signs
Infectious disease
Previous clinical study within 2 weeks
Don't agree to participate
Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
Previous adverse effects that contraindicate extended lens wear.
Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

senofilcon A toric bilaterally

balafilcon A toric bilaterally

senofilcon A/balafilcon A contralaterally

Arm Description

senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.

Outcomes

Primary Outcome Measures

Corneal Staining

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Limbal Redness

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Bulbar Redness

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Tarsal Roughness

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Secondary Outcome Measures

Full Information

NCT ID

NCT00762502

First Posted

September 26, 2008

Last Updated

June 18, 2018

Sponsor

Johnson & Johnson Vision Care, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00762502

Brief Title

Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Official Title

Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.

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

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

senofilcon A toric bilaterally

Arm Type

Active Comparator

Arm Description

senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Arm Title

balafilcon A toric bilaterally

Arm Type

Active Comparator

Arm Description

balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Arm Title

senofilcon A/balafilcon A contralaterally

Arm Type

Active Comparator

Arm Description

senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.

Intervention Type

Device

Intervention Name(s)

senofilcon A toric contact lens

Intervention Description

soft contact lens

Intervention Type

Device

Intervention Name(s)

balafilcon A toric contact lens

Intervention Description

soft contact lens

Primary Outcome Measure Information:

Title

Corneal Staining

Description

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Time Frame

at 3 months of lens wear (period 1)

Title

Limbal Redness

Description

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Time Frame

at 3 months of lens wear (period 1)

Title

Bulbar Redness

Description

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Time Frame

at 3 months of lens wear (period 1)

Title

Tarsal Roughness

Description

Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Time Frame

at 3 months of lens wear (period 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to wear study lenses in parameters available Non-presbyopes between the ages of 18-45 Understand and sign informed consent Willing to follow the protocol Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10) Adapted soft contact lens wearer Swims no more than once a week Has a wearable pair of spectacles. Exclusion Criteria: Any ocular or systemic disorder which may contraindicate contact lens wear Any topical ocular medication Aphakic Corneal refractive surgery Corneal distortion from hard CL wear or keratoconus Pregnant or lactating Grade 2 or worse slit lamp signs Infectious disease Previous clinical study within 2 weeks Don't agree to participate Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks Previous adverse effects that contraindicate extended lens wear. Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Facility Information:

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

021115

Country

United States

City

Newtown

State/Province

New South Wales

ZIP/Postal Code

2042

Country

Australia

City

Camberwell

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

City

Hawthorn

State/Province

Victoria

ZIP/Postal Code

3122

Country

Australia

City

Keilor

State/Province

Victoria

ZIP/Postal Code

3036

Country

Australia

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

City

Mitcham

State/Province

Victoria

ZIP/Postal Code

3132

Country

Australia

City

Moe

State/Province

Victoria

ZIP/Postal Code

3825

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

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