Clinical trial NCT00584220: Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: Astigmatism
vision
comfort
satisfaction
contact lenses
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Foresight Regulatory Strategies, Inc.
First posted: 2008-01-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Subjective Reported Vision
timeFrame: 1 week
measure: Subject Reported Lens Comfort.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Jason Chin, O.D.
role: PRINCIPAL_INVESTIGATOR
name: James Fujimoto, O.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Arthur T. Kobayashi, O.D., Inc.
name: Weslie Hamada, O.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Care Associates of Hawaii
name: Dennis Kuwuabara, O.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mark E. Nakano Optometric Corp.
name: Mark Nakano, O.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unaffilliated
name: Ikuko Sugimoto, O.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Drs. Farkas, Kassalow, Resnick & Associates
name: Kevin Rosin, O.D.
role: PRINCIPAL_INVESTIGATOR
name: Jennifer Kao, O.D.
role: PRINCIPAL_INVESTIGATOR
References: