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

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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: alphafilcon A toric; Device: senofilcon A toric

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

1. 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).
2. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy.
3. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
4. be able and willing to adhere to the instructions set forth in the protocol.
5. 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.
6. 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
7. have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
8. be in good general health, based on his/her knowledge.
9. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion Criteria:

1. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
2. 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.
3. 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).

4. 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
5. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
6. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
7. Aphakia, keratoconus or a highly irregular cornea.
8. Current pregnancy or lactation (to the best of the subject's knowledge).
9. Active participation in another clinical study at any time during this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: senofilcon A toric / alphafilcon A toric; senofilcon A toric contact lenses worn daily during the first period, then alphafilcon A toric contact lenses worn daily during the second period	Device: alphafilcon A toric; contact lens; Other Names: SofLens66 Toric; Device: senofilcon A toric; contact lens
Other: alphafilcon A toric / senofilcon A toric; alphafilcon A toric contact lenses worn daily during the first period, then senofilcon A toric contact lenses worn daily during the second period	Device: alphafilcon A toric; contact lens; Other Names: SofLens66 Toric; Device: senofilcon A toric; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week
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.	1 week

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Foresight Regulatory Strategies, Inc.
• Investigators: Principal Investigator: Jason Chin, O.D.; Principal Investigator: James Fujimoto, O.D.; Principal Investigator: Dennis Kuwuabara, O.D., Eye Care Associates of Hawaii; Principal Investigator: Mark Nakano, O.D., Mark E. Nakano Optometric Corp.; Principal Investigator: Kevin Rosin, O.D., Drs. Farkas, Kassalow, Resnick & Associates; Principal Investigator: Jennifer Kao, O.D.; Principal Investigator: Weslie Hamada, O.D., Arthur T. Kobayashi, O.D., Inc.; Principal Investigator: Ikuko Sugimoto, O.D., unaffilliated

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 31, 2007
• First Posted (Estimate): January 2, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: comfort; satisfaction; Astigmatism; contact lenses; vision
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-0714B