Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03713281
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: Toric Multifocal etafilcon A with PVP

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Although study includes one arm, Participant is masked to the identity of the investigational product.
• Primary Purpose: Treatment
• Official Title: Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population
• Actual Study Start Date: Oct 4, 2018
• Actual Primary Completion Date: Feb 19, 2019
• Actual Study Completion Date: Feb 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Lens Subjects between the ages 40 to 70 years of age and who are adapted contact lens wearers with astigmatism in both eyes will be assigned to the same Test Lens according to the lens wear schedule.	Device: Toric Multifocal etafilcon A with PVP; Investigational

Outcome Measures

Primary Outcome Measures

1. Distance Visual Acuity (logMAR) [2-Week Follow-up]

   High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.

2. Near Visual Acuity (logMAR) [2-Week Follow-up]

   High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 at least 40 and not more than 70 years of age at the time of screening.

4. The subject's distance spherical component of their refraction must be in the range of +1.25 D to +3.75 D in each eye.

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 +1.50 D in each eye.

7. Subject's refractive cylinder axis must be within 90°±30° or 180°±30° in each eye.

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

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

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

Exclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or lactating.

2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.

3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).

4. 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.

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

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

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

8. Any current ocular infection or inflammation.

9. Any current ocular abnormality that may interfere with contact lens wear.

10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.

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 or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

15. Any known hypersensitivity or allergic reaction to Eye-Cept® rewetting drop solution.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Eye Care PA	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 12, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03713281
• Other Study ID Numbers: CR-6278
• First Posted: Oct 19, 2018
• Last Update Posted: Mar 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Recruitment Details	In total, 30 subjects were enrolled in this study of which, 28 subjects were assigned and dispensed a study lens, while 2 subjects failed to meet all eligibility criteria. Of the total dispensed subjects, 25 completed the study and 3 subjects were discontinued.

Arm/Group Title	Toric Multifocal Etafilcon A With PVP
Arm/Group Description	All subjects that were disepnsed the sudy lens.
Period Title: Overall Study
STARTED	28
COMPLETED	25
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Toric Multifocal Etafilcon A With PVP
Arm/Group Description	All subjects dispensed a study lens.
Overall Participants	28
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	51.8 (4.98)
Sex: Female, Male (Count of Participants)
Female	21 75%
Male	7 25%
Race/Ethnicity, Customized (Number) [Number]
Black or African American	3 10.7%
White	24 85.7%
Other	1 3.6%
Region of Enrollment (Count of Participants)
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	Distance Visual Acuity (logMAR)
Description	High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Time Frame	2-Week Follow-up

Outcome Measure Data

Analysis Population Description

All sub jects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.

Arm/Group Title	Toric Multifocal Etafilcon A With PVP
Arm/Group Description	All subjects that were dispensed the study lens.
Measure Participants	23
Mean (Standard Deviation) [logMAR]	-0.13 (0.095)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Toric Multifocal Etafilcon A With PVP
	Comments	Statistically superiority will be concluded if the upper confidence limit will be less than 0.10 logMAR.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least-square mean
	Estimated Value	-0.131
	Confidence Interval	(2-Sided) 95%; -0.208 to -0.054
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0278
	Estimation Comments

2. Primary Outcome

Title	Near Visual Acuity (logMAR)
Description	High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Time Frame	2-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.

Arm/Group Title	Toric Multifocal Etafilcon A With PVP
Arm/Group Description	All subjects that were dispensed the study lens.
Measure Participants	23
Mean (Standard Deviation) [logMAR]	0.06 (0.080)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Toric Multifocal Etafilcon A With PVP
	Comments	Statistically superiority will be concluded if the upper confidence limit will be less than 0.17 logMAR for near distance logMAR visual acuity.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least-square means
	Estimated Value	0.060
	Confidence Interval	(2-Sided) 95%; -0.017 to 0.137
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0278
	Estimation Comments

Adverse Events

Time Frame	Throughout the duration of the study. Approximately 2 weeks per subject.
Arm/Group Title	Toric Multifocal Etafilcon A With PVP
Arm/Group Description	All subjects dispensed a stud lens.
All Cause Mortality
	Toric Multifocal Etafilcon A With PVP
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Serious Adverse Events
	Toric Multifocal Etafilcon A With PVP
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	Toric Multifocal Etafilcon A With PVP
	Affected / at Risk (%)	# Events
Total	0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.