Evaluation of Astigmatic Contact Lenses

Visual Acuity Clinical Trial

Official title:

Evaluation of Astigmatic Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086447
• Other study ID #: CR-5871
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 4, 2017

Study information

• Verified date: June 2018
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate that the investigational contact lens meets the design requirements related to corneal staining, lens fit, visual acuity and rotational performance as well as subjective comfort and handling. Subjects will wear the contact lenses for a total of 28-36 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Investigational Contact Lens
Senofilcon C Toric
• Marketed Contact Lens
Air Optix for Astigmatism

Locations

Country	Name	City	State
United States	ABQ Eye Care	Albuquerque	New Mexico
United States	Premier Vision	Amarillo	Texas
United States	Indiana University School of Optometry	Bloomington	Indiana
United States	ProCare Vision Centers	Granville	Ohio
United States	Dr. James Weber & Associates, PA	Jacksonville	Florida
United States	Edward S. Wygonik, OD	Jacksonville Beach	Florida
United States	Sabal Eye Care	Longwood	Florida
United States	Maitland Vision Center	Maitland	Florida
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	EyeCare Professionals of Powell	Powell	Ohio
United States	Botetourt Eyecare, LLC	Salem	Virginia
United States	William J Bogus, OD, FAAO	Salt Lake City	Utah
United States	Sacco Eye Group	Vestal	New York
United States	West Bay Eye Associates	Warwick	Rhode Island
United States	Professional Vision Care, Inc	Westerville	Ohio
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular Distance Visual Acuity (VA)	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
Primary	Lens Fit Acceptance	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
Primary	Lens Stability With Blink	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
Primary	Absolute Lens Rotation	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
Primary	Corneal Staining	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	Overall Comfort	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
Secondary	Overall Handling	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
Secondary	Monocular Distance Visual Acuity (VA)	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