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Colorado Springs, Colorado 80909

  • Vision Correction

Purpose:

Evaluate and compare the clinical performance of three toric contact lenses amongst 660 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics, as well as corneal integrity. As of May 7, 2008 study will consist of no more than 330 eligible subjects.


Study summary:

Up to 44 sites, 22 in the US and 22 in Canada will participate. Each investigator will only use one control lens type, though all sites will have the test lens. There will be a maximum of 4 scheduled visits: Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible) Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing Visit 4: 2 week follow-up 14 days (±3) after dispensing As of May 7, 2008 study will consist of 22 sites in the US only.


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.


Study is Available At:


Original ID:

CR-0801


NCT ID:

NCT00638846


Secondary ID:

CTOR-501


Study Acronym:


Brief Title:

Performance of Two Silicone Hydrogel Torics


Official Title:

Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vistakon


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

276


Enrollment Type:

Actual


Overall Contact Information

Official Name:Graeme YOung, MPhil PhD
Study Director

Study Dates

Start Date:February 2008
Completion Date:May 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 10, 2010
First Received Date:March 10, 2008
First Results Date:June 18, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall Corneal Staining
Time Frame:After 2 weeks use
Safety Issues:False
Description:National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abradsion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurr
Outcome Type:Secondary Outcome
Measure:Subjective Lens Vision
Time Frame:measured at 1 and 2 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Time to Fit Lens
Time Frame:after lens insertion
Safety Issues:False
Description:Time required for the optometrist to fit the lens.
Outcome Type:Primary Outcome
Measure:Subjective Comfort
Time Frame:measured at 1 and 2 weeks
Safety Issues:False
Description: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. Analysis was p
Outcome Type:Primary Outcome
Measure:Lens Stability
Time Frame:10-15 minutes after insertion
Safety Issues:False
Description:Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
Outcome Type:Primary Outcome
Measure:Lens Orientation
Time Frame:1 minute after insertion
Safety Issues:False
Description:Proportion of eyes with lens orientation within 5 degress of optimal

Study Interventions

Intervention Type:Device
Name:senofilcon A toric
Description:silicone hydrogel toric lens, 2 wk replacement
Arm Name:senofilcon A toric
Other Name:ACUVUE OASYS
Intervention Type:Device
Name:balafilcon A toric
Description:silicone hydrogel toric, 2 wk replacement
Arm Name:balafilcon A toric
Other Name:PureVision Toric

Study Arms

Study Arm Type:Experimental
Arm Name:senofilcon A toric
Description:senofilcon A, daily wear, toric contact lens
Study Arm Type:Active Comparator
Arm Name:balafilcon A toric
Description:balafilcon A, daily wear, toric contact lens

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Vistakon

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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