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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: senofilcon A toric contact lens; Device: alphafilcon A toric; Device: etafilcon A sphere

• Registration Number: NCT00584727
• 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 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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Results First Submitted: 2008-12-05
• Results First Submitted QC: 2010-01-22
• Results First Posted: 2010-02-10
• 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

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

Primary Outcome Measures

Name	Time	Method
Visual Acuity	15-20 minutes	Number of eyes with Distance Visual Acuity 20/20 or better
Lens Stability Within 5 Degrees	1 minute	Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.
Patient Reported Vision	15-20 minutes	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	1 minute	Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.
Patient Reported Comfort.	15-20 minutes	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	end of study	This outcome measures which lens the subjects preferred to wear.