Comparison of Two Toric Contact Lenses on Current Toric Wearers

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

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

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: senofilcon A toric; Device: alphafilcon A 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

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: senofilcon A; senofilcon A toric daily wear contact lenses	Device: senofilcon A toric; silicone hydrogel toric lens, 2 wk replacement, daily wear; Other Names: 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 Names: SofLens Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Orientation Within 5 Degrees	Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.	1 minute after insertion
Lens Stability	Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.	10-15 minutes after insertion
Subjective Lens Comfort	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.	1 and 2 weeks
Subjective 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. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.	1 and 2 weeks
Overall Corneal Staining	Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.	after 2 weeks use

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: March 13, 2008
• First Submitted That Met QC Criteria: March 19, 2008
• First Posted (Estimate): March 20, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: comfort; vision; toric contact lenses; toric fit characteristics; slit lamp findings
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-0802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No