Evaluation of Etafilcon A Daily Disposable Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02061592
• Collaborator: (none)
• Enrollment: 136
• Locations: 7
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site: 19.4
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

To evaluate the clinical performance of daily disposable etafilcon A lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: etafilcon A; Device: etafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Etafilcon A Control Lens etafilcon A	Device: etafilcon A
Experimental: Etafilcon A Test Lens etafilcon A	Device: etafilcon A

Outcome Measures

Primary Outcome Measures

1. Overall Comfort [1-week follow-up]

   Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.

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

   Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.

3. Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim [1-week follow-up]

   LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.

4. Monocular logMar Visual Acuity - Standard Low Contrast Bright [1- week Follow-up]

   LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

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

• The subject must be at least 18 and not more than 70 years of age.

• The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.

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

• The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.

• The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.

• The subject must self-report their race as Asian

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

• The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

Exclusion Criteria:

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

• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

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

• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.

• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), etc.).

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

• Any ocular infection.

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

• Monovision or multi-focal contact lens correction.

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

• History of binocular vision abnormality or strabismus.

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

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

• History of serious mental illness.

• History of seizures.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Jacksonville	Florida	United States
2		'Aiea	Hawaii	United States
3		Honolulu	Hawaii	United States
4		Kahului	Hawaii	United States
5		Waipahu	Hawaii	United States
6		New York	New York	United States
7		Houston	Texas	United States

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02061592
• Other Study ID Numbers: CR-5553
• First Posted: Feb 13, 2014
• Last Update Posted: Jun 19, 2018
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	128 of the 136 subjects were randomized. 8 subjects did not meet the eligibility criteria. 3 subjects were discontinued from the study. 12 subjects were excluded from analysis due to major protocol deviations. 113 subjects completed all study visits without a major protocol deviation.

Arm/Group Title	Control/Test	Test/Control
Arm/Group Description	Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.	Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
Period Title: Period 1
STARTED	66	62
COMPLETED	64	62
NOT COMPLETED	2	0
Period Title: Period 1
STARTED	64	62
COMPLETED	64	61
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Control/Test	Test/Control	Total
Arm/Group Description	Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.	Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A	Total of all reporting groups
Overall Participants	66	62	128
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (9.02)	30.6 (7.48)	31.0 (8.29)
Sex: Female, Male (Count of Participants)
Female	52 78.8%	51 82.3%	103 80.5%
Male	14 21.2%	11 17.7%	25 19.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	66 100%	62 100%	128 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	66 100%	62 100%	128 100%

Outcome Measures

1. Primary Outcome

Title	Overall Comfort
Description	Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Time Frame	1-week follow-up

Outcome Measure Data

Analysis Population Description

Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.

Arm/Group Title	Control	Test
Arm/Group Description	Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.	Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
Measure Participants	113	113
Mean (Standard Deviation) [units on a scale]	60.1 (18.47)	43.6 (20.19)

2. Primary Outcome

Title	Overall Vision
Description	Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Time Frame	1- week Follow-up

Outcome Measure Data

Analysis Population Description

Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.

Arm/Group Title	Control	Test
Arm/Group Description	Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.	Subjects who received Test lens, etafilcon A, in either the first week or last week of the study.
Measure Participants	113	113
Mean (Standard Deviation) [units on a scale]	64.9 (18.23)	58.0 (19.51)

3. Primary Outcome

Title	Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim
Description	LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Time Frame	1-week follow-up

Outcome Measure Data

Analysis Population Description

Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.

Arm/Group Title	Control	Test
Arm/Group Description	Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.	Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
Measure Participants	100	100
Measure Eyes	200	200
Mean (Standard Deviation) [LogMar]	0.030 (0.088)	0.020 (0.085)

4. Primary Outcome

Title	Monocular logMar Visual Acuity - Standard Low Contrast Bright
Description	LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Time Frame	1- week Follow-up

Outcome Measure Data

Analysis Population Description

Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.

Arm/Group Title	Control	Test
Arm/Group Description	Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.	Subjects who received Test lens, etafilcon A , in either the first week or last week of the study.
Measure Participants	113	113
Measure Eyes	226	226
Mean (Standard Deviation) [LogMar]	0.060 (0.083)	0.050 (0.079)

Adverse Events

Time Frame	One week for each intervention
Adverse Event Reporting Description	Safety Population included all subjects who were administered at least 1 test article.
Arm/Group Title	Control		Test
Arm/Group Description	Subjects who received control lens etafilcon A in either the first or the last week of the study .		Subjects who received the test lens, etafilcon A, in either the first week or the last week of the study.
All Cause Mortality
	Control		Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/113 (0%)
Other (Not Including Serious) Adverse Events
	Control		Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/113 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Prior to submission for publication or presentation the Institution will provide sponsor with at least sixty (60) days for review of a manuscript. If needed, the Institution and Principal Investigator will withhold publication for up to an additional sixty days to allow for filing of a patent application.