Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03701516
• Collaborator: (none)
• Enrollment: 268
• Locations: 12
• Arms: 2
• Actual Duration (Months): 6.2
• Patients Per Site: 22.3
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: etafilcon A with novel molding process; Device: etafilcon A with current molding process	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 268 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
• Actual Study Start Date: Sep 24, 2018
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TEST/CONTROL Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence.	Device: etafilcon A with novel molding process; TEST Lens; Device: etafilcon A with current molding process; CONTROL Lens
Experimental: CONTROL/TEST Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence.	Device: etafilcon A with novel molding process; TEST Lens; Device: etafilcon A with current molding process; CONTROL Lens

Outcome Measures

Primary Outcome Measures

1. Overall Comfort Scores [1-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.

2. Overall Vision Scores [1-week Follow-up]

   Overall vision was assessed using the CLUE questionnaire. CLUE is a validated 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 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.

Secondary Outcome Measures

1. Average Daily Wear Time [1-week Follow-up]

   Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type.

2. LLHC LogMAR Visual Performance [1-week Follow-up]

   Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.

3. HLLC LogMAR Visual Performance [1-week Follow-up]

   Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 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. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.

4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).

5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.

7. The subject's refractive cylinder must be < 0.75 D in each eye.

8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

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

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.

3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

4. Any ocular infection.

5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

6. Monovision or multi-focal contact lens correction.

7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

8. History of binocular vision abnormality or strabismus.

9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).

10. Suspicion of or recent history of alcohol or substance abuse.

11. History of serious mental illness.

12. History of seizures.

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

14. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.

15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale.

16. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EyeCenter Optometrics	Rocklin	California	United States	95677
2	Fleming Island Vision Center	Fleming Island	Florida	United States	32258
3	Bartram Eye Clinic	Jacksonville	Florida	United States	32258
4	Sabal Eye Care	Longwood	Florida	United States	32779
5	Maitland Vision Center	Maitland	Florida	United States	32751
6	St. Johns Eye Associates	Saint Augustine	Florida	United States	32092
7	Sacco Eye Group	Vestal	New York	United States	13850
8	ProCare Vision Centers	Granville	Ohio	United States	43023
9	Eyecare Professionals of Powell	Powell	Ohio	United States	43065
10	Primary Eyecare Group	Brentwood	Tennessee	United States	37027
11	Total Eye Care, PA	Memphis	Tennessee	United States	38119
12	Boutetourt Eyecare, LLC	Salem	Virginia	United States	24153

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 6, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03701516
• Other Study ID Numbers: CR-6307
• First Posted: Oct 10, 2018
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	A total of 268 subjects were enrolled in this study. Of those enrolled, 263 dispensed at least one study lens while, 5 subjects failed to meet all eligibility criteria. Of those dispensed subjects, 252 subjects completed the study while, 11 subjects were discontinued from the study.

Arm/Group Title	Test/Control	Control/Test
Arm/Group Description	Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period.	Subjects randomized to receive the Control lens during the first period and then receive the Test lens during the second period.
Period Title: Period 1
STARTED	131	132
COMPLETED	127	127
NOT COMPLETED	4	5
Period Title: Period 1
STARTED	127	127
COMPLETED	126	126
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Dispensed Subject
Arm/Group Description	All subjects dispensed a study lens.
Overall Participants	263
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.6 (8.5)
Sex: Female, Male (Count of Participants)
Female	186 70.7%
Male	77 29.3%
Race/Ethnicity, Customized (participants) [Number]
Asian	13 4.9%
Black or African American	17 6.5%
White	228 86.7%
Other	5 1.9%
Region of Enrollment (Count of Participants)
United States	263 100%

Outcome Measures

1. Primary Outcome

Title	Overall Comfort Scores
Description	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.
Time Frame	1-week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Arm/Group Title	Test	Control
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	237	237
Mean (Standard Deviation) [unit on a scale]	59.9 (24.21)	60.8 (24.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 98%; -4.53 to 3.85
	Parameter Dispersion	Type: Standard Deviation; Value: 1.781
	Estimation Comments	Mean difference was calculated as Test - Control

2. Primary Outcome

Title	Overall Vision Scores
Description	Overall vision was assessed using the CLUE questionnaire. CLUE is a validated 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 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.
Time Frame	1-week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Arm/Group Title	Test	Control
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	237	237
Mean (Standard Deviation) [unit on a scale]	64.2 (20.06)	66.5 (19.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-2.34
	Confidence Interval	(2-Sided) 98%; -5.36 to 0.61
	Parameter Dispersion	Type: Standard Deviation; Value: 1.263
	Estimation Comments	Mean difference was calculated as Test - Control

3. Secondary Outcome

Title	Average Daily Wear Time
Description	Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type.
Time Frame	1-week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Arm/Group Title	Test	Control
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	237	237
Mean (Standard Deviation) [Hours]	14.3 (1.92)	14.4 (1.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -1.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.22 to 0.10
	Parameter Dispersion	Type: Standard Deviation; Value: 0.083
	Estimation Comments	Mean difference was calculated as Test - Control

4. Secondary Outcome

Title	LLHC LogMAR Visual Performance
Description	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.
Time Frame	1-week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Arm/Group Title	Test	Control
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	237	237
Measure eyes	474	474
Mean (Standard Deviation) [logMAR]	-0.059 (0.1123)	-0.060 (0.1176)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	0.001
	Confidence Interval	(2-Sided) 95%; -0.005 to 0.006
	Parameter Dispersion	Type: Standard Deviation; Value: 0.0028
	Estimation Comments	Mean difference was calculated as Test - Control

5. Secondary Outcome

Title	HLLC LogMAR Visual Performance
Description	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.
Time Frame	1-week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Arm/Group Title	Test	Control
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	237	237
Measure eyes	474	474
Mean (Standard Deviation) [logMAR]	0.062 (0.1209)	0.065 (0.1176)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.003
	Confidence Interval	(2-Sided) 95%; -0.009 to 0.002
	Parameter Dispersion	Type: Standard Deviation; Value: 0.0029
	Estimation Comments	Mean difference was calculated as Test - Control

Adverse Events

Time Frame	Throughout the duration of the study, approximately 2 weeks per subject.
Arm/Group Title	Test		Control
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.		Subjects that wore the Control lens in either the first or second period of the study.
All Cause Mortality
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/263 (0%)		0/263 (0%)
Serious Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/263 (0%)		0/263 (0%)
Other (Not Including Serious) Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/263 (0%)		0/263 (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.