Clinical trial NCT00638846: Performance of Two Silicone Hydrogel Toric Contact Lenses
Official title: Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Correction
Keywords: toric contact lenses
vision
comfort
toric fit characteristics
slit lamp findings
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 45 years of age.
* Sign Written Informed Consent (See separate document).
* Be an existing successful daily wear toric soft contact lens.
* Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
* Does not require presbyopic correction (can read J1 @ normal reading distance).
* Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
* Have refractive astigmatism between 0.75D and 2.50D in both eyes.
* Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  * No amblyopia.
  * No evidence of lid abnormality or infection.
  * No conjunctival abnormality or infection.
  * No clinically significant slit lamp findings (i.e. stromal edema, vascularisation, infiltrates or abnormal opacities).
  * No other active ocular disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Corneal staining Grade 3 in more than one region.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
* Extended lens wear in last 3 months.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Pregnancy, lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or in last 60 days.

Primary outcomes:
measure: Lens Orientation
timeFrame: 1 minute after insertion
measure: Lens Stability
timeFrame: 10-15 minutes after insertion
measure: Subjective Comfort
timeFrame: 2 weeks of lens wear
Secondary outcomes:
measure: Time to Fit Lens
timeFrame: after lens insertion
measure: Subjective Lens Vision
timeFrame: measured at 1 and 2 weeks
measure: Overall Corneal Staining
timeFrame: After 2 weeks use
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Camp Eye Care Clinic
state: Arkansas
city: Mission Viejo
country: United States
facility: James R. Dugue, O.D.
state: California
city: Colorado Springs
country: United States
facility: Executive Park Eye Care
state: Colorado
city: Jacksonville
country: United States
facility: Dr. Ted Brink and Associates
state: Florida
city: Neodesha
country: United States
facility: Grene Vision Group
state: Kansas
city: Raytown
country: United States
facility: Advanced Eyecare, PC
state: Missouri
city: Florence
country: United States
facility: Dr. James Brobst
state: New Jersey
city: Rochester
country: United States
facility: Fine Eye Care Associates
state: New York
city: Warren
country: United States
facility: Warren Ophthalmology Associates
state: Ohio
city: Kittanning
country: United States
facility: Selden Eyecare LLC
state: Pennsylvania
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
city: Warwick
country: United States
facility: Dr. David W. Ferris and Associates
state: Rhode Island
city: Chamberlain
country: United States
facility: Dr. Larry Menning
state: South Dakota
city: Katy
country: United States
facility: Wishnow-Sugar Vision Group
state: Texas
city: Salt Lake City
country: United States
facility: Dr. William Bogus
state: Utah
city: Midlothian
country: United States
facility: Midlothian Optometric Center
state: Virginia
city: Virginia Beach
country: United States
facility: The Eye Specialists, Ltd.
state: Virginia
city: Bremerton
country: United States
facility: The Eye & Contact Lens Clinic
state: Washington
city: Franklin
country: United States
facility: Matus Eyecare
state: Wisconsin
Study officials:
name: Graeme YOung, MPhil PhD
role: STUDY_DIRECTOR
References: