- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086447
Evaluation of Astigmatic Contact Lenses
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Whittier, California, United States, 90606
- Golden Optometric Group
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Florida
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Jacksonville, Florida, United States, 32205
- Dr. James Weber & Associates, PA
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Jacksonville Beach, Florida, United States, 32250
- Edward S. Wygonik, OD
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Longwood, Florida, United States, 32779
- Sabal Eye Care
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Maitland, Florida, United States, 32751
- Maitland Vision Center
-
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Indiana
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Bloomington, Indiana, United States, 47405
- Indiana University School of Optometry
-
-
Kansas
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Pittsburg, Kansas, United States, 66762
- Kannarr Eye Care
-
-
New Mexico
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Albuquerque, New Mexico, United States, 87109
- ABQ Eye Care
-
-
New York
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Vestal, New York, United States, 13850
- Sacco Eye Group
-
-
Ohio
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Granville, Ohio, United States, 43023
- Procare Vision Centers
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Powell, Ohio, United States, 43065
- EyeCare Professionals of Powell
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Westerville, Ohio, United States, 43081
- Professional Vision Care, Inc
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Rhode Island
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Warwick, Rhode Island, United States, 02888
- West Bay Eye Associates
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Tennessee
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Memphis, Tennessee, United States, 38119
- Total Eye Care, PA
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-
Texas
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Amarillo, Texas, United States, 79119
- Premier Vision
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Utah
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Salt Lake City, Utah, United States, 84106
- William J Bogus, OD, FAAO
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Virginia
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Salem, Virginia, United States, 24153
- Botetourt Eyecare, LLC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1) Healthy adult males or females age ≥18-40 years of age with signed informed consent.
2) The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3) Subject must be a habitual soft toric contact lens wearer. Habitual wearer is defined as someone who wears contact lenses for at least 6 hours a day, 5 days a week for the past 30 days.
4) Subject's vertex corrected spherical component of their distance refraction must be between -1.00 to -4.75 Diopter (D) (inclusive) in each eye.
5) Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 DC (inclusive) in each eye.
6) Subject's refractive cylinder axis must be 180±25 and 90±15 in each eye. 7) The subject must have visual acuity best correctable to 20/25 or better for each eye 8) The subject must read and sign the Informed Consent form.
Exclusion Criteria:
1) Women who are pregnant or breastfeeding, 2) Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
3) Any ocular medications use within the last one month. 4) Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
5) Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
6) Habitual wearer of extended wear contact lenses. 7) Known sensitivity to Revitalens OcuTec® 8) Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
9) A clinical finding or history of entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report.
10) History of binocular vision abnormality or strabismus, by self-report. 11) Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
12) Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
13) Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
14) Clinically significant (grade 3 or higher) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities which would contraindicate contact lens wear.
15) Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
16) Any active ocular infection. 17) Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
18) Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Participating Subjects
Subjects who are habitual soft toric contact lens wearers, aged 18 to 40 years of age, will be dispensed the investigational contact lens to be worn from 28-36 days, to include a total of 5 visits.
|
Senofilcon C Toric
|
Active Comparator: Control: Participating Subjects
Subjects who are habitual soft toric contact lens wearers, aged 18 to 40 years of age, will be dispensed marketed contact lens to be worn from 28-36 days, to include a total of 5 visits.
|
Air Optix for Astigmatism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocular Distance Visual Acuity (VA)
Time Frame: Up to 4-Week Follow-up
|
Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study.
Observed VA data collected during all planned visits were dichotomized whether VA was "20/40 or better (acceptable VA)" or "worse than 20/40 (unacceptable VA)".
VA of 20/40 with a negative modifier was considered worse than 20/40.
The number of eye with acceptable VA was reported for each study lens.
|
Up to 4-Week Follow-up
|
Lens Fit Acceptance
Time Frame: 15 Minutes Post Lens Fitting
|
Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness.
Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic.
The number of eyes with acceptable lens fit was reported for each study lens.
|
15 Minutes Post Lens Fitting
|
Lens Stability With Blink
Time Frame: 15 Minutes Post Lens Fitting
|
Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated.
The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability).
The number of eye with acceptable stability was reported for each lens.
|
15 Minutes Post Lens Fitting
|
Absolute Lens Rotation
Time Frame: 15-minutes Post Lens Insertion
|
Lens rotation was assessed using slit lamp with beam that can be rotated.
The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation).
The number of eyes with acceptable lens rotation for each lens was reported.
|
15-minutes Post Lens Insertion
|
Corneal Staining
Time Frame: Up to 4-Week Follow-up
|
Contact lens related corneal staining was assessed using slit lamp throughout the study.
Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe.
Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS).
The number of eyes with Grade 3 or higher was reported for each lens type.
|
Up to 4-Week Follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Comfort
Time Frame: Up to 4- Week Follow-up
|
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire.
CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
|
Up to 4- Week Follow-up
|
Overall Handling
Time Frame: Up to 4- Week Follow-up
|
Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire.
CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
|
Up to 4- Week Follow-up
|
Monocular Distance Visual Acuity (VA)
Time Frame: 15 Minutes Post Lens Fitting
|
Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet.
Observed VA data collected at fitting were dichotomized whether VA was "20/20 or better (optimal VA)" or "worse than 20/20".
VA of 20/20 with a negative modifier was considered worse than 20/20.
The number of eyes with 20/20 vision was reported for each study lens.
|
15 Minutes Post Lens Fitting
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CR-5871
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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