Comparison of Two Toric Contact Lenses on Current Toric Wearers
Primary Purpose
Ametropia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
senofilcon A toric
alphafilcon A toric
Sponsored by
About this trial
This is an interventional treatment trial for Ametropia focused on measuring toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
Eligibility Criteria
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.
Sites / Locations
- Ted Brink and Associates
- Eola Eyes
- Clayton Eye Center
- The Koetting Associates Inc.
- Southern Eyes
- Western Reserve Vision Care
- Primary Eyecare Group, P.C.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
senofilcon A
alphafilcon A
Arm Description
senofilcon A toric daily wear contact lenses
alphafilcon A toric daily wear contact lenses
Outcomes
Primary Outcome Measures
Lens Orientation Within 5 Degrees
Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Lens Stability
Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00639379
First Posted
March 13, 2008
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00639379
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia
Keywords
toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
senofilcon A
Arm Type
Experimental
Arm Description
senofilcon A toric daily wear contact lenses
Arm Title
alphafilcon A
Arm Type
Active Comparator
Arm Description
alphafilcon A toric daily wear contact lenses
Intervention Type
Device
Intervention Name(s)
senofilcon A toric
Other Intervention Name(s)
ACUVUE OASYS
Intervention Description
silicone hydrogel toric lens, 2 wk replacement, daily wear
Intervention Type
Device
Intervention Name(s)
alphafilcon A toric
Other Intervention Name(s)
SofLens Toric
Intervention Description
hydrogel toric lens, 2 wk replacement, daily wear
Primary Outcome Measure Information:
Title
Lens Orientation Within 5 Degrees
Description
Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Time Frame
1 minute after insertion
Title
Lens Stability
Description
Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Time Frame
10-15 minutes after insertion
Title
Subjective Lens Comfort
Description
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.
Time Frame
1 and 2 weeks
Title
Subjective Vision
Description
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.
Time Frame
1 and 2 weeks
Title
Overall Corneal Staining
Description
Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time Frame
after 2 weeks use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ted Brink and Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Eola Eyes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
The Koetting Associates Inc.
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Facility Name
Southern Eyes
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Western Reserve Vision Care
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Primary Eyecare Group, P.C.
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Toric Contact Lenses on Current Toric Wearers
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