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

This study has been completed.
Sponsor:
Collaborator:
Foresight Regulatory Strategies, Inc.
Information provided by:
Vistakon
ClinicalTrials.gov Identifier:
NCT00584220
First received: December 20, 2007
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Astigmatism
Device: senofilcon A toric
Device: alphafilcon A toric

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Subjective Reported Vision [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Enrollment: 96
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: senofilcon A toric
contact lens
Device: alphafilcon A toric
contact lens
Other Name: SofLens66 Toric
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: senofilcon A toric
contact lens
Device: alphafilcon A toric
contact lens
Other Name: SofLens66 Toric

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584220

Sponsors and Collaborators
Vistakon
Foresight Regulatory Strategies, Inc.
Investigators
Principal Investigator: Jason Chin, O.D.
Principal Investigator: James Fujimoto, O.D.
Principal Investigator: Weslie Hamada, O.D. 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. Unaffilliated
Principal Investigator: Kevin Rosin, O.D. Drs. Farkas, Kassalow, Resnick & Associates
Principal Investigator: Jennifer Kao, O.D.
  More Information

No publications provided

Responsible Party: Kurt Moody, OD, FAAO./ Manager, Clinical Research, Vistakon
ClinicalTrials.gov Identifier: NCT00584220     History of Changes
Other Study ID Numbers: CR-0714B
Study First Received: December 20, 2007
Results First Received: August 21, 2009
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vistakon:
Astigmatism
vision
comfort
satisfaction
contact lenses

Additional relevant MeSH terms:
Astigmatism
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on October 21, 2014