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

NCT00584727 | Completed Results

• 1 other identifier: CR-0714A
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Astigmatism

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Visual Acuity

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

  15-20 minutes

• 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.

  15-20 minutes

• 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.

  1 minute

• 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.

  1 minute

• 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

  15-20 minutes

• Patient Preference

  This outcome measures which lens the subjects preferred to wear.

  end of study

Study Arms (6)

senofilcon A/alphafilcon A/etafilcon A

ACTIVE COMPARATOR

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

Device: senofilcon A toric contact lens; Device: alphafilcon A toric; Device: etafilcon A sphere

alphafilcon A/etafilcon A/senofilcon A

ACTIVE COMPARATOR

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

Device: senofilcon A toric contact lens; Device: alphafilcon A toric; Device: etafilcon A sphere

etafilcon A/senofilcon A/alphafilcon A

ACTIVE COMPARATOR

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

Device: senofilcon A toric contact lens; Device: alphafilcon A toric; Device: etafilcon A sphere

senofilcon A/etafilcon A/alphafilcon A

ACTIVE COMPARATOR

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

Device: senofilcon A toric contact lens; Device: alphafilcon A toric; Device: etafilcon A sphere

alphafilcon A/senofilcon A/etafilcon A

ACTIVE COMPARATOR

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

Device: senofilcon A toric contact lens; Device: alphafilcon A toric; Device: etafilcon A sphere

etafilcon A/alphafilcon A/senofilcon A

ACTIVE COMPARATOR

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

Device: senofilcon A toric contact lens; Device: alphafilcon A toric; Device: etafilcon A sphere

Interventions

senofilcon A toric contact lens DEVICE

contact lens

alphafilcon A/etafilcon A/senofilcon A; alphafilcon A/senofilcon A/etafilcon A; etafilcon A/alphafilcon A/senofilcon A; etafilcon A/senofilcon A/alphafilcon A; senofilcon A/alphafilcon A/etafilcon A; senofilcon A/etafilcon A/alphafilcon A

alphafilcon A toric DEVICE

contact lens

alphafilcon A/etafilcon A/senofilcon A; alphafilcon A/senofilcon A/etafilcon A; etafilcon A/alphafilcon A/senofilcon A; etafilcon A/senofilcon A/alphafilcon A; senofilcon A/alphafilcon A/etafilcon A; senofilcon A/etafilcon A/alphafilcon A

etafilcon A sphere DEVICE

contact lens

alphafilcon A/etafilcon A/senofilcon A; alphafilcon A/senofilcon A/etafilcon A; etafilcon A/alphafilcon A/senofilcon A; etafilcon A/senofilcon A/alphafilcon A; senofilcon A/alphafilcon A/etafilcon A; senofilcon A/etafilcon A/alphafilcon A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Foresight Regulatory Strategies, Inc.: collaborator

MeSH Terms

Conditions

Astigmatism; Personal Satisfaction

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Behavior

Results Point of Contact

• Title: Kurt Moody, OD, FAAO
• Organization: Vistakon

904-443-3088

Study Officials

• Jason Chin, O.D.

  PRINCIPAL INVESTIGATOR

• James Fujimoto, O.D.

  PRINCIPAL INVESTIGATOR

• Weslie Hamada, OlD.

  Arthur T. Kobayashi, O.D., Inc.

  PRINCIPAL INVESTIGATOR

• Dennis Kuwuabara, O.D.

  Eye Care Associates of Hawaii

  PRINCIPAL INVESTIGATOR

• Mark Nakano, O.D.

  Mark E. Nakano Optometric Corp.

  PRINCIPAL INVESTIGATOR

• Ikuko Sugimoto, O.D.

  PRINCIPAL INVESTIGATOR

• Kevin Rosin, O.D.

  Drs. Farkas, Kassalow, Resnick & Associates

  PRINCIPAL INVESTIGATOR

• Jennifer Kao, O.D.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: September 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 21, 2015
• Results First Posted: February 10, 2010

Record last verified: 2015-05