Clinical Evaluation of Multifocal Toric Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03208088
• Collaborator: (none)
• Enrollment: 96
• Locations: 7
• Arms: 10
• Actual Duration (Months): 1.3
• Patients Per Site: 13.7
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Device: etafilcon A Investigational Toric Multifocal Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Multifocal Toric Contact Lenses
• Actual Study Start Date: Jun 12, 2017
• Actual Primary Completion Date: Jul 21, 2017
• Actual Study Completion Date: Jul 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 2 etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 3 etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 4 etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 5 etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 6 etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 7 etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 8 etafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 9 etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens
Experimental: Sequence 10 etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator)	Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 1; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 2; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Tes Lens 3; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Test Lens 4; Device: etafilcon A Investigational Toric Multifocal Contact Lens; Control Lens

Outcome Measures

Primary Outcome Measures

1. Overall Handling Comparison Between Test 1/Test 2 and Control [15 minutes]

   Overall handling 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.

Secondary Outcome Measures

1. Overall Handling Comparison Between Test 3/Test 4 and Control [15 minutes]

   Overall handling 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.

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 between 40 and 70 years of age.

4. The subject's distance refraction must be in the range of -1.50 D to -4.50 D.

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 +2.50 D in each eye

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

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

9. The subject must be an adapted soft contact lens wearer in both eyes (ie, worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration)

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

Exclusion Criteria:

1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear

2. Pregnancy or lactation

3. Currently diagnosed with diabetes

4. Infectious diseases (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, HIV).

5. 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

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

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

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

9. Any ocular infection or inflammation

10. Any ocular abnormality that may interfere with contact lens wear

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 of clinical site (eg, Investigator, Coordinator, Technician).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Golden Optometric Group	Whittier	California	United States	90606
2	Bay Hill Eye Care	Orlando	Florida	United States	32819
3	Lee & Leong Doctors of Optometry	Kahului	Hawaii	United States	96732
4	Spectrum Eyecare	Jamestown	New York	United States	14750
5	Sacco Eye Group	Vestal	New York	United States	13850
6	Miamisburg Vision Care	Miamisburg	Ohio	United States	45342
7	Optometry Group, PLLC	Memphis	Tennessee	United States	38111

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 31, 2017

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03208088
• Other Study ID Numbers: CR-5935
• First Posted: Jul 5, 2017
• Last Update Posted: Sep 10, 2020
• Last Verified: Aug 1, 2020

• 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

Study Results

Participant Flow

Recruitment Details	A total of 96 subjects were enrolled in this study, of which 91 subjects were assigned at least 1 study lens, 5 subjects failed to meet all eligibility criteria. Of the total assigned subjects, 88 completed the study, while 3 were discontinued.
Pre-assignment Detail	Subjects were randomized to 1 of 10 unique lens sequences.

Arm/Group Title	Test 3/Test 2/Test 4/Test 1/Control	Test 3/Test 4/Test 2/Control/Test 1	Test 1/Control/Test 2/Test 4/Test 3	Test 1/Test 2/Control/Test 3/Test 4	Control/Test 1/Test 4/Test 2/Test 3	Control/Test 4/Test 1/Test 3/Test 2	Test 2/Test 3/Test 1/Test 4 /Control	Test 2/Test 1/Test 3/Control/Test 4	Test 4/Test 3/Control/Test 2/Test 1	Test 4/Control/Test 3/Test 1/Test 2
Arm/Group Description	Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Test 4 in period 3, Test 1 in period 4, Control in period 5.	Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 4 in period 2, Test 2 in period 3, Control in period 4, Test 1 in period 5.	Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, Test 4 in period 4, Test 3 in period 5.	Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Test 2 in period 2, Control in period 3, Test 3 in period 4, Test 4 in period 5.	Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 1 in period 2, Test 4 in period 3, Test 2 in period 4, Test 3 in period 5.	Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 4 in period 2, Test 1 in period 3, Test 3 in period 4, Test 2 in period 5.	Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 3 in period 2, Test 1 in period 3, Test 4 in period 4, Control in period 5.	Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, Control in period 4, Test 4 in period 5.	Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Test 3 in period 2, Control in period 3, Test 2 in period 4, Test 1 in period 5.	Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Control in period 2, Test 3 in period 3, Test 1 in period 4, Test 2 in period 5.
Period Title: Period 1
STARTED	10	9	10	9	9	9	8	10	8	9
COMPLETED	10	9	10	9	9	9	8	10	8	9
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1
STARTED	10	9	10	9	9	9	8	10	8	9
COMPLETED	10	9	10	9	9	9	8	10	7	9
NOT COMPLETED	0	0	0	0	0	0	0	0	1	0
Period Title: Period 1
STARTED	10	9	10	9	9	9	8	10	7	9
COMPLETED	10	9	10	8	9	9	8	10	7	9
NOT COMPLETED	0	0	0	1	0	0	0	0	0	0
Period Title: Period 1
STARTED	10	9	10	8	9	9	8	10	7	9
COMPLETED	10	9	10	7	9	9	8	10	7	9
NOT COMPLETED	0	0	0	1	0	0	0	0	0	0
Period Title: Period 1
STARTED	10	9	10	7	9	9	8	10	7	9
COMPLETED	10	9	10	7	9	9	8	10	7	9
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Completed Subjects
Arm/Group Description	All subjects who were administered study article and completed all required study visits.
Overall Participants	88
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	51.1 (7.59)
Sex: Female, Male (Count of Participants)
Female	62 70.5%
Male	26 29.5%
Race/Ethnicity, Customized (Number) [Number]
Asian	7 8%
Black or African American	7 8%
White	73 83%
Other	1 1.1%
Region of Enrollment (Number) [Number]
United States	88 100%

Outcome Measures

1. Primary Outcome

Title	Overall Handling Comparison Between Test 1/Test 2 and Control
Description	Overall handling 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	15 minutes

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 1	Test 2	Control
Arm/Group Description	Subjects that wore the Test 1 lens in either the first, second, third, fourth, or fifth period of the study.	Subjects that wore the Test 2 lens in either the first, second, third, fourth, or fifth period of the study.	Subjects that wore the Control lens in either the first, second, third, fourth, or fifth period of the study.
Measure Participants	67	67	67
Mean (Standard Deviation) [units on a scale]	57.1 (21.34)	53.3 (22.47)	52.3 (23.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test 1, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	5.9
	Confidence Interval	(2-Sided) 95%; 0.1 to 11.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.92
	Estimation Comments	LS Mean difference was calculated as Test 1 - Control.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Test 2, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; -4.0 to 8.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.06
	Estimation Comments	LS Mean difference was calculated as Test 2 - Control.

2. Secondary Outcome

Title	Overall Handling Comparison Between Test 3/Test 4 and Control
Description	Overall handling 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	15 minutes

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 3	Test 4	Control
Arm/Group Description	Subjects that wore the Test 3 lens in either the first, second, third, fourth, or fifth period of the study.	Subjects that wore the Test 4 lens in either the first, second, third, fourth, or fifth period of the study.	Subjects that wore the Control lens in either the first, second, third, fourth, or fifth period of the study.
Measure Participants	67	67	67
Mean (Standard Deviation) [units on a scale]	50.7 (22.59)	49.1 (22.83)	52.3 (23.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test 1, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean difference
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -7.5 to 4.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.06
	Estimation Comments	LS Mean difference was calculated as Test 3 - Control.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Test 2, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean
	Estimated Value	-3.4
	Confidence Interval	(2-Sided) 95%; -9.0 to 2.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.88
	Estimation Comments	LS Mean difference was calculated as Test 4 - Control.

Adverse Events

Time Frame	Throughout the duration of the study. Approximately 1 week per subject.
Arm/Group Title	Test 1		Test 2		Test 3		Test 4		Control
Arm/Group Description	Subjects that wore the Test 1 lens in either the first, second, third, fourth, or fifth period of the study.		Subjects that wore the Test 2 lens in either the first, second, third, fourth, or fifth period of the study.		Subjects that wore the Test 3 lens in either the first, second, third, fourth, or fifth period of the study.		Subjects that wore the Test 4 lens in either the first, second, third, fourth, or fifth period of the study.		Subjects that wore the Control lens in either the first, second, third, fourth, or fifth period of the study.
All Cause Mortality
	Test 1		Test 2		Test 3		Test 4		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/90 (0%)		0/90 (0%)		0/89 (0%)		0/90 (0%)
Serious Adverse Events
	Test 1		Test 2		Test 3		Test 4		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/90 (0%)		0/90 (0%)		0/89 (0%)		0/90 (0%)
Other (Not Including Serious) Adverse Events
	Test 1		Test 2		Test 3		Test 4		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/90 (0%)		0/90 (0%)		0/89 (0%)		0/90 (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.