TEMPO: Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01467557
• Collaborator: (none)
• Enrollment: 1,171
• Locations: 37
• Duration (Months): 24
• Patients Per Site: 31.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Device: narafilcon B daily disposable soft contact lenses; Device: etafilcon A daily disposable soft contact lenses

Study Design

• Study Type: Observational
• Actual Enrollment: 1171 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
1-Day ACUVUE TruEye contact lens users 1-Day ACUVUE TruEye contact lens users	Device: narafilcon B daily disposable soft contact lenses; daily disposable soft contact lenses; Other Names: 1-Day ACUVUE TruEye
1-Day ACUVUE MOIST contact lens users 1-Day ACUVUE MOIST contact lens users	Device: etafilcon A daily disposable soft contact lenses; daily disposable soft contact lenses; Other Names: 1-Day ACUVUE MOIST

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [Self-report at 2 Week, 4 Month or 12 Month surveys]

   Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel.

Secondary Outcome Measures

1. Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys [Baseline, 2 Week, 4 Month or 12 Month surveys]

   The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Wearers of 1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® daily disposable soft contact lenses in both eyes aged >8 years of age who have recently begun use of that lens type and have purchased at least 3 month supply of lenses.

• The registrant must read and sign the Informed Consent form. Minor subjects must obtain parental signature of Informed Consent and also sign an Informed Assent Form.

• The registrant must sign the Release of Medical Records in the event of an adverse event in the study.

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

Exclusion Criteria:

• Previously wearing the type of lenses with which they are registering (1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® Daily Disposable lenses).

• Current participant in an unrelated research study.

• Employee or family member of Recruiting Practitioner or Johnson & Johnson.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Campbell	California	United States	95008
2		Fullerton	California	United States	92831-1615
3		Huntington Beach	California	United States	92647
4		Los Angeles	California	United States	90049
5		Mountain View	California	United States	94041
6		Newport Beach	California	United States	92660
7		Salinas	California	United States	93901
8		San Francisco	California	United States	94103
9		San Francisco	California	United States	94111
10		San Francisco	California	United States	94158
11		San Jose	California	United States	95131
12		Sunnyvale	California	United States	94086
13		Washington	District of Columbia	United States	20016
14		Boca Raton	Florida	United States	33431-7253
15		Boca Raton	Florida	United States	33432-3938
16		Fort Lauderdale	Florida	United States	33316
17		Fort Lauderdale	Florida	United States	33328-2018
18		North Miami	Florida	United States	33181
19		Pembroke Pines	Florida	United States	33024
20		Wellington	Florida	United States	33414
21		Roswell	Georgia	United States	30075
22		Des Moines	Iowa	United States	50310
23		Shreveport	Louisiana	United States	71105
24		Belmont	Massachusetts	United States	02478
25		Cambridge	Massachusetts	United States	02138
26		Dedham	Massachusetts	United States	02026
27		Lake Hopatcong	New Jersey	United States	07849
28		New York	New York	United States	10022
29		New York	New York	United States	10036
30		Charlotte	North Carolina	United States	28210
31		Gastonia	North Carolina	United States	28054
32		Cleveland	Ohio	United States	43081
33		Johnstown	Ohio	United States	43031
34		Westerville	Ohio	United States	43081
35		Brentwood	Tennessee	United States	37027-7552
36		Amarillo	Texas	United States	79119
37		Milwaukee	Wisconsin	United States	53227

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: NCT01467557
• Other Study ID Numbers: CR-005059
• First Posted: Nov 8, 2011
• Last Update Posted: Jun 19, 2018
• Last Verified: Oct 1, 2015

• Keywords provided by Johnson & Johnson Vision Care, Inc.: adverse events
• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Arm/Group Title	1-Day ACUVUE TruEye Contact Lens Users	1-Day ACUVUE MOIST Contact Lens Users
Arm/Group Description	1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses	1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses
Period Title: Overall Study
STARTED	601	570
2 Week Survey Completed	551	522
4 Month Survey Completed	533	493
12 Month Survey Completed	502	463
COMPLETED	502	463
NOT COMPLETED	99	107

Baseline Characteristics

Arm/Group Title	1-Day ACUVUE TruEye Contact Lens Users	1-Day ACUVUE MOIST Contact Lens Users	Total
Arm/Group Description	1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses	1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses	Total of all reporting groups
Overall Participants	601	570	1171
Age (Count of Participants)
<=18 years	106 17.6%	121 21.2%	227 19.4%
Between 18 and 65 years	484 80.5%	445 78.1%	929 79.3%
>=65 years	11 1.8%	4 0.7%	15 1.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.2 (13.9)	30.3 (12.9)	31.8 (13.5)
Sex: Female, Male (Count of Participants)
Female	400 66.6%	392 68.8%	792 67.6%
Male	201 33.4%	178 31.2%	379 32.4%
Region of Enrollment (participants) [Number]
United States	601 100%	570 100%	1171 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Adverse Events
Description	Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel.
Time Frame	Self-report at 2 Week, 4 Month or 12 Month surveys

Outcome Measure Data

Analysis Population Description

The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)

Arm/Group Title	1-Day ACUVUE TruEye Contact Lens Users	1-Day ACUVUE MOIST Contact Lens Users
Arm/Group Description	1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.	1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.
Measure Participants	601	570
Corneal Infiltrative Events	2 0.3%	0 0%
CL-Related Adverse Events with Office Visit	8 1.3%	3 0.5%
Not CL-Related Adverse Events with Office Visit	5 0.8%	2 0.4%
"Yes" to Red Eye Question, but no Office Visit	6 1%	5 0.9%

2. Secondary Outcome

Title	Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys
Description	The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).
Time Frame	Baseline, 2 Week, 4 Month or 12 Month surveys

Outcome Measure Data

Analysis Population Description

The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points.

Arm/Group Title	1-Day ACUVUE TruEye Contact Lens Users	1-Day ACUVUE MOIST Contact Lens Users
Arm/Group Description	1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.	1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.
Measure Participants	418	400
Baseline, n=368, 320	12.8 (7.2)	12.3 (7.2)
2 weeks, n=418,400	7.3 (5.2)	8.0 (5.5)
4 months, n=418,400	8.7 (5.7)	9.3 (6.2)
12 months, n=418,400	9.0 (6.3)	9.2 (6.1)

Adverse Events

Arm/Group Title	1-Day ACUVUE TruEye Contact Lens Users		1-Day ACUVUE MOIST Contact Lens Users
Arm/Group Description	1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.		1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.
All Cause Mortality
	1-Day ACUVUE TruEye Contact Lens Users		1-Day ACUVUE MOIST Contact Lens Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1-Day ACUVUE TruEye Contact Lens Users		1-Day ACUVUE MOIST Contact Lens Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/601 (0%)		0/570 (0%)
Other (Not Including Serious) Adverse Events
	1-Day ACUVUE TruEye Contact Lens Users		1-Day ACUVUE MOIST Contact Lens Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/601 (0%)		0/570 (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.