Expired Study
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Beachwood, Ohio 44122


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


Study summary:

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


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.


Study is Available At:


Original ID:

CR-0802


NCT ID:

NCT00639379


Secondary ID:


Study Acronym:


Brief Title:

Comparison of Two Toric Contact Lenses on Current Toric Wearers


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


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: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

89


Enrollment Type:

Actual


Study Dates

Start Date:February 2008
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:August 2010
Last Changed Date:August 27, 2010
First Received Date:March 13, 2008
First Results Date:June 18, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Lens Orientation Within 5 Degrees
Time Frame:1 minute after insertion
Safety Issues:False
Description:Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Outcome Type:Primary Outcome
Measure:Lens Stability
Time Frame:10-15 minutes after insertion
Safety Issues:False
Description:Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Outcome Type:Primary Outcome
Measure:Subjective Lens Comfort
Time Frame:1 and 2 weeks
Safety Issues:False
Description:A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most postive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test a
Outcome Type:Primary Outcome
Measure:Subjective Vision
Time Frame: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 postive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and
Outcome Type:Primary Outcome
Measure:Overall Corneal Staining
Time Frame:after 2 weeks use
Safety Issues:False
Description:Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

Study Interventions

Intervention Type:Device
Name:alphafilcon A toric
Description:hydrogel toric lens, 2 wk replacement, daily wear
Arm Name:alphafilcon A
Other Name:SofLens Toric
Intervention Type:Device
Name:senofilcon A toric
Description:silicone hydrogel toric lens, 2 wk replacement, daily wear
Arm Name:senofilcon A
Other Name:ACUVUE OASYS

Study Arms

Study Arm Type:Active Comparator
Arm Name:alphafilcon A
Description:alphafilcon A toric daily wear contact lenses
Study Arm Type:Experimental
Arm Name:senofilcon A
Description:senofilcon A toric daily wear contact lenses

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: October 09, 2019

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