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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: senofilcon A toric; Device: alphafilcon A toric

• Registration Number: NCT00584220
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Results First Submitted: 2009-08-21
• Results First Submitted QC: 2010-01-28
• Results First Posted: 2010-02-19
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
senofilcon A toric / alphafilcon 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
alphafilcon A toric / senofilcon A toric	alphafilcon 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
alphafilcon A toric / senofilcon 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
senofilcon A toric / alphafilcon A toric	senofilcon 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

Primary Outcome Measures

Name	Time	Method
Subject Reported Lens Comfort.	1 week	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.
Subjective Reported Vision	1 week	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.