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

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03605303
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Days): 2
• Patients Per Site Per Month: 45.7

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
Refractive Error Correction	Device: Test/Control; Device: Control/Test	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 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
• Actual Study Start Date: Jul 3, 2018
• Actual Primary Completion Date: Jul 5, 2018
• Actual Study Completion Date: Jul 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CONTROL- etafilcon A current molding 1-Day ACUVUE® MOIST	Device: Test/Control; Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments; Device: Control/Test; Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments
Experimental: TEST- etafilcon A novel molding Investigational Contact Lens	Device: Test/Control; Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments; Device: Control/Test; Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments

Outcome Measures

Primary Outcome Measures

1. Overall Comfort Scores [1-Week Follow-up]

   Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

2. Overall Vision Score [1-Week Follow-up]

   Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

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:

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 of investigational clinic (e.g., Investigator, Coordinator, Technician).

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 - May 30, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03605303
• Other Study ID Numbers: CR-6270
• First Posted: Jul 30, 2018
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• 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: Refractive Errors

Study Results

Participant Flow

Recruitment Details	On July 06, 2018 Johnson & Johnson Vision terminated this study prematurely after lens testing revealed that the lens thickness in the mid-periphery of the lens were thinner than the lens design targets. As of this date only 3 subjects were enrolled at 1 site.

Arm/Group Title	Test/Control	Control/Test
Arm/Group Description	Subjects that were radnomized to wear the Test lens during the period and the Control lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.	Subjects that were radnomized to wear the Control lens during the period and the Test lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
Period Title: Period 1
STARTED	2	1
COMPLETED	0	0
NOT COMPLETED	2	1
Period Title: Period 1
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All subjects enrolled into th study
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 66.7%
Male	1 33.3%
Race/Ethnicity, Customized (Number) [Number]
Black or African American	1 33.3%
White	1 33.3%
Native Hawaiian or Other Pacfic Islander	1 33.3%

Outcome Measures

1. Primary Outcome

Title	Overall Comfort Scores
Description	Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Study terminated early. No data was analyzed.

Arm/Group Title	Test	Control
Arm/Group Description	subjects that were randomized to receive the Test lens in either period of the study.	All subject that were randomized to the Control lens during either period of the study.
Measure Participants	0	0

2. Primary Outcome

Title	Overall Vision Score
Description	Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Study terminated early. No data was analyzed.

Arm/Group Title	Test	Control
Arm/Group Description	subjects that were randomized to receive the Test lens in either period of the study.	All subject that were randomized to the Control lens during either period of the study.
Measure Participants	0	0

Adverse Events

Time Frame	Throughout the entire duration of the study. Approxmiately 3 days per subject.
Arm/Group Title	Test		Control
Arm/Group Description	Subjects that wore the Test lens during any time throughout the duration of the study.		Subjects that wore the Control lens during any time throughout the duration of the study.
All Cause Mortality
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Serious Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)

Limitations/Caveats

This study was terminated after additional lens metrology testing revealed that the lens thickness of the contact lenses were thinner than the lens design targets. This reduction in thickness may have altered the handling of the contact lenses.

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.