Performance of Two Silicone Hydrogel Toric Contact Lenses

Vision Correction Clinical Trial

Official title:

Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638846
• Other study ID #: CR-0801
• Secondary ID: CTOR-501
• Status: Completed
• Phase: N/A
• First received: March 10, 2008
• Last updated: May 5, 2015
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vision Correction

Intervention

Device:
• senofilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
• balafilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)

Locations

Country	Name	City	State
United States	The Eye & Contact Lens Clinic	Bremerton	Washington
United States	Dr. Larry Menning	Chamberlain	South Dakota
United States	Executive Park Eye Care	Colorado Springs	Colorado
United States	Dr. James Brobst	Florence	New Jersey
United States	Matus Eyecare	Franklin	Wisconsin
United States	Dr. Ted Brink and Associates	Jacksonville	Florida
United States	Wishnow-Sugar Vision Group	Katy	Texas
United States	Selden Eyecare LLC	Kittanning	Pennsylvania
United States	Midlothian Optometric Center	Midlothian	Virginia
United States	James R. Dugue, O.D.	Mission Viejo	California
United States	Grene Vision Group	Neodesha	Kansas
United States	Camp Eye Care Clinic	North Little Rock	Arkansas
United States	Advanced Eyecare, PC	Raytown	Missouri
United States	Fine Eye Care Associates	Rochester	New York
United States	Dr. William Bogus	Salt Lake City	Utah
United States	Nittany Eye Associates	State College	Pennsylvania
United States	The Eye Specialists, Ltd.	Virginia Beach	Virginia
United States	Warren Ophthalmology Associates	Warren	Ohio
United States	Dr. David W. Ferris and Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Orientation	Proportion of eyes with lens orientation within 5 degrees of optimal	1 minute after insertion	No
Primary	Lens Stability	Lens stability is measured as the amount of rotation induced from blink after the lens has settled.	10-15 minutes after insertion	No
Primary	Subjective Comfort	Subjective comfort was derived from 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. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.	2 weeks of lens wear	No
Secondary	Time to Fit Lens	Time required for the optometrist to fit the lens.	after lens insertion	No
Secondary	Subjective Lens Vision	A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.	measured at 1 and 2 weeks	No
Secondary	Overall Corneal Staining	National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.	After 2 weeks use	No