Comparison of Two Toric Contact Lenses on Current Toric Wearers
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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 |
- 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 |
Inclusion Criteria:
- 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).
- Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
- Be a currently successful wearer for at least 3 months of B&L SofLens 66 Toric hydrogel lenses.
- Be able and willing to adhere to the instructions set forth in the protocol.
- 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.
- 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).
- Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
- Be in good general health, based on his/her knowledge.
- 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:
- Presbyopic or has the need for a near add for reading.
- Previous refractive surgery; current or previous orthokeratology treatment.
- Aphakia, keratoconus or a highly irregular cornea.
- 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).
- A known history of corneal hypoesthesia (reduced corneal sensitivity.)
- Anterior uveitis or iritis (past or present).
- A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
- Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
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
- Current pregnancy or lactation (to the best of the subject's knowledge).
- Actively participating in another clinical study at any time during this study.
Contacts and 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 | |
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: | October 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vistakon:
|
toric contact lenses vision comfort toric fit characteristics slit lamp findings |
Additional relevant MeSH terms:
|
Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013