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

December 20, 2007
March 14, 2014
September 2007
December 2007   (final data collection date for primary outcome measure)
  • 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.
  • Patient reported vision satisfaction. [ Time Frame: Baseline, 1-wk and 2-wks ] [ Designated as safety issue: No ]
  • Patient reported comfort satisfaction. [ Time Frame: Baseline, 1-wk and 2-wks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00584220 on ClinicalTrials.gov Archive Site
Not Provided
Patient reported overall satisfaction. [ Time Frame: Baseline, 1-wk and 2-wks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Astigmatism
  • Device: senofilcon A toric
    contact lens
  • Device: alphafilcon A toric
    contact lens
    Other Name: SofLens66 Toric
  • 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
    Interventions:
    • Device: senofilcon A toric
    • Device: alphafilcon A 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
    Interventions:
    • Device: senofilcon A toric
    • Device: alphafilcon A toric
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00584220
CR-0714B
No
Kurt Moody, OD, FAAO./ Manager, Clinical Research, Vistakon
Vistakon
Foresight Regulatory Strategies, Inc.
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.
Vistakon
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP