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In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

senofilcon A toric contact lens

alphafilcon A toric

etafilcon A sphere

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring astigmatism, visual acuity, fit, comfort, satisfaction, contact lens

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy
have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
be able and willing to adhere to the instructions set forth in the protocol.
agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
be in good general health, based on his/her knowledge.
read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion Criteria:

The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium or corneal scars within the visual axis
- Neovascularization >1mm in from the limbus
- History of giant papillary conjunctivitis (GPC) worse than Grade 2
- Anterior uveitis or iritis (past or present)
- Seborrhoeic eczema, seborrhoeic conjunctivitis
A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
A known history of corneal hypoesthesia (reduced corneal sensitivity.)
Aphakia, keratoconus or a highly irregular cornea.
Current pregnancy or lactation (to the best of the subject's knowledge).
Active participation in another clinical study at any time during this study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Arm Label

senofilcon A/alphafilcon A/etafilcon A

alphafilcon A/etafilcon A/senofilcon A

etafilcon A/senofilcon A/alphafilcon A

senofilcon A/etafilcon A/alphafilcon A

alphafilcon A/senofilcon A/etafilcon A

etafilcon A/alphafilcon A/senofilcon A

Arm Description

First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses

First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses

First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses

First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses

Outcomes

Primary Outcome Measures

Visual Acuity

Number of eyes with Distance Visual Acuity 20/20 or better

Patient Reported Vision

A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision.

Lens Orientation Within 5 Degrees

Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.

Lens Stability Within 5 Degrees

Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.

Patient Reported Comfort.

A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable

Patient Preference

This outcome measures which lens the subjects preferred to wear.

Secondary Outcome Measures

Full Information

NCT ID

NCT00584727

First Posted

December 20, 2007

Last Updated

May 5, 2015

Sponsor

Johnson & Johnson Vision Care, Inc.

Collaborators

Foresight Regulatory Strategies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00584727

Brief Title

In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens

Official Title

Evaluation of Fit and Visual Acuity of the Cypress Toric Lens in Two Phases: Part A: A Non-Dispensing Comparison to SofLens66® Toric and Acuvue® 2

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Johnson & Johnson Vision Care, Inc.

Collaborators

Foresight Regulatory Strategies, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.

Detailed Description

Non-dispensing, single-masked (subject-masked), randomised, controlled study.

6. Conditions and Keywords

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

Astigmatism

Keywords

astigmatism, visual acuity, fit, comfort, satisfaction, contact lens

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

senofilcon A/alphafilcon A/etafilcon A

Arm Type

Active Comparator

Arm Description

First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

Arm Title

alphafilcon A/etafilcon A/senofilcon A

Arm Type

Active Comparator

Arm Description

First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses

Arm Title

etafilcon A/senofilcon A/alphafilcon A

Arm Type

Active Comparator

Arm Description

First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses

Arm Title

senofilcon A/etafilcon A/alphafilcon A

Arm Type

Active Comparator

Arm Description

First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses

Arm Title

alphafilcon A/senofilcon A/etafilcon A

Arm Type

Active Comparator

Arm Description

First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

Arm Title

etafilcon A/alphafilcon A/senofilcon A

Arm Type

Active Comparator

Arm Description

First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses

Intervention Type

Device

Intervention Name(s)

senofilcon A toric contact lens

Intervention Description

contact lens

Intervention Type

Device

Intervention Name(s)

alphafilcon A toric

Intervention Description

contact lens

Intervention Type

Device

Intervention Name(s)

etafilcon A sphere

Intervention Description

contact lens

Primary Outcome Measure Information:

Title

Visual Acuity

Description

Number of eyes with Distance Visual Acuity 20/20 or better

Time Frame

15-20 minutes

Title

Patient Reported Vision

Description

Time Frame

15-20 minutes

Title

Lens Orientation Within 5 Degrees

Description

Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.

Time Frame

1 minute

Title

Lens Stability Within 5 Degrees

Description

Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.

Time Frame

1 minute

Title

Patient Reported Comfort.

Description

Time Frame

15-20 minutes

Title

Patient Preference

Description

This outcome measures which lens the subjects preferred to wear.

Time Frame

end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed). be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study. be able and willing to adhere to the instructions set forth in the protocol. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye. be in good general health, based on his/her knowledge. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT. Exclusion Criteria: The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc). Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium or corneal scars within the visual axis Neovascularization >1mm in from the limbus History of giant papillary conjunctivitis (GPC) worse than Grade 2 Anterior uveitis or iritis (past or present) Seborrhoeic eczema, seborrhoeic conjunctivitis A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections. A known history of corneal hypoesthesia (reduced corneal sensitivity.) Aphakia, keratoconus or a highly irregular cornea. Current pregnancy or lactation (to the best of the subject's knowledge). Active participation in another clinical study at any time during this study.

Overall Study Officials: