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Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

senofilcon A toric

alphafilcon A toric

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Astigmatism, vision, comfort, satisfaction, contact lenses

Eligibility Criteria

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

Inclusion Criteria: Prior to being considered eligible to participate in this study, subjects MUST

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 Type

Other

Arm Label

senofilcon A toric / alphafilcon A toric

alphafilcon A toric / senofilcon A toric

Arm Description

senofilcon A toric contact lenses worn daily during the first period, then alphafilcon A toric contact lenses worn daily during the second period

alphafilcon A toric contact lenses worn daily during the first period, then senofilcon A toric contact lenses worn daily during the second period

Outcomes

Primary Outcome Measures

Subjective Reported Vision

A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision.

Subject Reported Lens Comfort.

A weighted combined score of one week and two week data 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 estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable.

Secondary Outcome Measures

Full Information

NCT ID

NCT00584220

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

NCT00584220

Brief Title

Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

Official Title

Evaluation of Fit and Visual Acuity of the Investigational Toric Lens in Two Phases: Part B: A Dispensing Cross-over Comparison to SofLens66 Toric

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 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 contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.

Detailed Description

Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.

6. Conditions and Keywords

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

Astigmatism

Keywords

Astigmatism, vision, comfort, satisfaction, contact lenses

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 toric / alphafilcon A toric

Arm Type

Other

Arm Description

senofilcon A toric contact lenses worn daily during the first period, then alphafilcon A toric contact lenses worn daily during the second period

Arm Title

alphafilcon A toric / senofilcon A toric

Arm Type

Other

Arm Description

alphafilcon A toric contact lenses worn daily during the first period, then senofilcon A toric contact lenses worn daily during the second period

Intervention Type

Device

Intervention Name(s)

senofilcon A toric

Intervention Description

contact lens

Intervention Type

Device

Intervention Name(s)

alphafilcon A toric

Other Intervention Name(s)

SofLens66 Toric

Intervention Description

contact lens

Primary Outcome Measure Information:

Title

Subjective Reported Vision

Description

Time Frame

1 week

Title

Subject Reported Lens Comfort.

Description

Time Frame

1 week

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: Prior to being considered eligible to participate in this study, subjects MUST 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: