Performance of Two Silicone Hydrogel Toric Contact Lenses

NCT00638846 | Completed Results

• 2 other identifiers: CR-0801CTOR-501
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 19

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.

Conditions

Vision Correction

Keywords

toric contact lenses; vision; comfort; toric fit characteristics; slit lamp findings

Outcome Measures

Primary Outcomes (3)

• Lens Orientation

  Proportion of eyes with lens orientation within 5 degrees of optimal

  1 minute after insertion

• Lens Stability

  Lens stability is measured as the amount of rotation induced from blink after the lens has settled.

  10-15 minutes after insertion

• 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

Secondary Outcomes (3)

• Time to Fit Lens

  after lens insertion

• Subjective Lens Vision

  measured at 1 and 2 weeks

• Overall Corneal Staining

  After 2 weeks use

Study Arms (2)

senofilcon A toric

EXPERIMENTAL

senofilcon A, daily wear, toric contact lens worn for two weeks

Device: senofilcon A toric

balafilcon A toric

ACTIVE COMPARATOR

balafilcon A, daily wear, toric contact lens worn for two weeks

Device: balafilcon A toric

Interventions

senofilcon A toric DEVICE

silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)

Also known as: ACUVUE OASYS

senofilcon A toric

balafilcon A toric DEVICE

silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)

Also known as: PureVision Toric

balafilcon A toric

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (19)

Camp Eye Care Clinic

North Little Rock, Arkansas, 72116, United States

Location

James R. Dugue, O.D.

Mission Viejo, California, 92691, United States

Location

Executive Park Eye Care

Colorado Springs, Colorado, 80909, United States

Location

Dr. Ted Brink and Associates

Jacksonville, Florida, 32256, United States

Location

Grene Vision Group

Neodesha, Kansas, 66757, United States

Location

Advanced Eyecare, PC

Raytown, Missouri, 64133, United States

Location

Dr. James Brobst

Florence, New Jersey, 08518, United States

Location

Fine Eye Care Associates

Rochester, New York, 14623, United States

Location

Warren Ophthalmology Associates

Warren, Ohio, 44484, United States

Location

Selden Eyecare LLC

Kittanning, Pennsylvania, 16201, United States

Location

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Location

Dr. David W. Ferris and Associates

Warwick, Rhode Island, 02886, United States

Location

Dr. Larry Menning

Chamberlain, South Dakota, 57325-0490, United States

Location

Wishnow-Sugar Vision Group

Katy, Texas, 77450, United States

Location

Dr. William Bogus

Salt Lake City, Utah, 84106, United States

Location

Midlothian Optometric Center

Midlothian, Virginia, 23113, United States

Location

The Eye Specialists, Ltd.

Virginia Beach, Virginia, 23455, United States

Location

The Eye & Contact Lens Clinic

Bremerton, Washington, 98310, United States

Location

Matus Eyecare

Franklin, Wisconsin, 53132, United States

Location

Results Point of Contact

• Title: Kurt Moody OD
• Organization: Vistakon

904-443-3088

Study Officials

• Graeme YOung, MPhil PhD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 19, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: July 19, 2010

Record last verified: 2015-05

Locations

US (19)