Clinical Evaluation of Multifocal Toric Contact Lenses

Visual Acuity Clinical Trial

Official title:

Clinical Evaluation of Multifocal Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208088
• Other study ID #: CR-5935
• Status: Completed
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: July 21, 2017

Study information

• Verified date: August 2020
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 21, 2017
• Est. primary completion date: July 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form

2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol

3. The subject must be between 40 and 70 years of age.

4. The subject's distance refraction must be in the range of -1.50 D to -4.50 D.

5. The subject's refractive cylinder must be -1.00 to -1.50 D in each eye

6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye

7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye

8. Subjects must own a wearable pair of spectacles if required for their distance vision

9. The subject must be an adapted soft contact lens wearer in both eyes (ie, worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration)

10. The subject must already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the "Presbyopic Systems Questionnaire".

Exclusion Criteria:

1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear

2. Pregnancy or lactation

3. Currently diagnosed with diabetes

4. Infectious diseases (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, HIV).

5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear

6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions

7. Any previous, or planned, ocular or intraocular surgery (eg, radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc)

8. A history of amblyopia, strabismus or binocular vision abnormality

9. Any ocular infection or inflammation

10. Any ocular abnormality that may interfere with contact lens wear

11. Use of any ocular medication, with the exception of rewetting drops

12. History of herpetic keratitis

13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment

14. Employee of clinical site (eg, Investigator, Coordinator, Technician).

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
• etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
• etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
• etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
• etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens

Locations

Country	Name	City	State
United States	Spectrum Eyecare	Jamestown	New York
United States	Lee & Leong Doctors of Optometry	Kahului	Hawaii
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Miamisburg Vision Care	Miamisburg	Ohio
United States	Bay Hill Eye Care	Orlando	Florida
United States	Sacco Eye Group	Vestal	New York
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	Overall Handling Comparison Between Test 1/Test 2 and Control	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.	15 minutes
Secondary	Overall Handling Comparison Between Test 3/Test 4 and Control	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.	15 minutes