Comparison of Two Toric Contact Lenses on Current Toric Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00639379
First received: March 13, 2008
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. 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


Condition Intervention
Ametropia
Device: senofilcon A toric
Device: alphafilcon A toric

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens Orientation Within 5 Degrees [ Time Frame: 1 minute after insertion ] [ Designated as safety issue: No ]
    Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.

  • Lens Stability [ Time Frame: 10-15 minutes after insertion ] [ Designated as safety issue: No ]
    Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.

  • Subjective Lens Comfort [ Time Frame: 1 and 2 weeks ] [ Designated as safety issue: No ]
    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, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.

  • Subjective Vision [ Time Frame: 1 and 2 weeks ] [ Designated as safety issue: No ]
    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. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.

  • Overall Corneal Staining [ Time Frame: after 2 weeks use ] [ Designated as safety issue: No ]
    Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.


Enrollment: 89
Study Start Date: February 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: senofilcon A
senofilcon A toric daily wear contact lenses
Device: senofilcon A toric
silicone hydrogel toric lens, 2 wk replacement, daily wear
Other Name: ACUVUE OASYS
Active Comparator: alphafilcon A
alphafilcon A toric daily wear contact lenses
Device: alphafilcon A toric
hydrogel toric lens, 2 wk replacement, daily wear
Other Name: SofLens Toric

Detailed Description:

Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 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, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed).
  2. Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
  3. Be a currently successful wearer for at least 3 months of B&L SofLens 66 Toric hydrogel lenses.
  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 spectacle spherical component between -1.00 D and -5.25 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 30° of the horizontal in both eyes (when the subject's prescription is presented in minus cylinder form).
  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. Must be given an explanation of the study objectives, lens and solutions usage requirements and visit schedule. The subject must read, indicate understanding of and agree to begin participation in the clinical study. The subject must then sign the Informed Consent Form in the presence of the Investigator or their designee.

Exclusion Criteria:

  1. Presbyopic or has the need for a near add for reading.
  2. Previous refractive surgery; current or previous orthokeratology treatment.
  3. Aphakia, keratoconus or a highly irregular cornea.
  4. The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).
  5. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
  6. Anterior uveitis or iritis (past or present).
  7. A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
  8. Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
  9. 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
    • Meibomian gland dysfunction, blepharitis, or seborrhoeic dermatitis
  10. Current pregnancy or lactation (to the best of the subject's knowledge).
  11. Actively participating in another clinical study at any time during this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639379

Locations
United States, Florida
Ted Brink and Associates
Jacksonville, Florida, United States, 32256
Eola Eyes
Orlando, Florida, United States, 32801
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
United States, Missouri
The Koetting Associates Inc.
St Louis, Missouri, United States, 63144
United States, North Carolina
Southern Eyes
Concord, North Carolina, United States, 28025
United States, Ohio
Western Reserve Vision Care
Beachwood, Ohio, United States, 44122
United States, Tennessee
Primary Eyecare Group, P.C.
Brentwood, Tennessee, United States, 37027
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00639379     History of Changes
Other Study ID Numbers: CR-0802
Study First Received: March 13, 2008
Results First Received: June 18, 2010
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vistakon:
toric contact lenses
vision
comfort
toric fit characteristics
slit lamp findings

ClinicalTrials.gov processed this record on September 16, 2014