Connecting Contact Lenses and Digital Technology

• Sponsor: State University of New York College of Optometry (Other)
• Overall Status: Completed
• CT.gov ID: NCT02921087
• Collaborator: Johnson & Johnson Vision Care, Inc. (Industry)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 10.6
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.

Condition or Disease	Intervention/Treatment	Phase
Asthenopia; Contact Lenses; Ocular Accommodation; Convergence, Excess	Device: Test Daily Disposable Soft Contact Lenses; Device: Control Daily Disposable Soft Contact Lenses	N/A

Detailed Description

This was a prospective, single site, randomized, double-masked, crossover pilot study. Subjects were randomized to begin with either multifocal or single vision distance contact lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing distance on digital devices for a similar age group to our study was 63 cm which would require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to provide an intermediate near addition without compromising distance vision as much as would be expected with higher add powers. The multifocal lens utilizes an aspheric center-near design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed. Adverse events were collected and assessed at each study visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Connecting Contact Lenses and Digital Technology
• Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Nov 20, 2017
• Actual Study Completion Date: Nov 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Test followed by control Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.	Device: Test Daily Disposable Soft Contact Lenses; Worn daily for 7 +/- 2 days; Device: Control Daily Disposable Soft Contact Lenses; Worn daily for 7 +/- 2 days
Other: Control followed by test Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.	Device: Test Daily Disposable Soft Contact Lenses; Worn daily for 7 +/- 2 days; Device: Control Daily Disposable Soft Contact Lenses; Worn daily for 7 +/- 2 days

Outcome Measures

Primary Outcome Measures

1. Subjective Symptom Improvement [Baseline and after 1 week of wearing each lens.]

   The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms).

Secondary Outcome Measures

1. Lens Preference [2 weeks]

   Based on two alternative forced choice method

2. Lag of Accommodation in Study Lenses [1 week]

   Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag.

3. Convergence Insufficiency Symptom Survey (CISS) [1 week]

   Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60.

4. Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) [1 week]

   CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms).

5. Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens [1 week]

   Measured via Modified Thorington

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 18 to 35 years of age

2. Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder

3. Current single-vision soft contact lens wearer

4. Monocular acuity of 20/25 or better in each eye (Snellen)

5. Self-reported minimum of 6 hours a day on digital devices

6. Self-reported complaint of eyestrain on digital devices

7. No ocular pathology and/or history of eye surgery

8. No history of strabismus or strabismus surgery

9. No gas permeable lens wear for at least 3 months

10. Subjects may not be optometrists, opticians or optometry students

Exclusion Criteria:

1. Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale

2. Negative Relative Accommodation (NRA) less than +1.50 D

3. Exophoria at near > 6 prism diopters10

4. Vertical phoria > 1 prism diopter

5. Presence of tropia

6. Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8)

7. Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SUNY College of Optometry	New York	New York	United States	10036

Sponsors and Collaborators

• State University of New York College of Optometry
• Johnson & Johnson Vision Care, Inc.

Investigators

• Principal Investigator: Danielle Iacono, OD, SUNY Optometry

Study Documents (Full-Text)

• Study Protocol - May 30, 2017
• Statistical Analysis Plan - Apr 27, 2018

More Information

Publications

• Chalmers RL, Begley CG, Moody K, Hickson-Curran SB. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis Sci. 2012 Oct;89(10):1435-42.
• Cooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.
• Efron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.
• Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.
• Fedtke C, Bakaraju RC, Ehrmann K, Chung J, Thomas V, Holden BA. Visual performance of single vision and multifocal contact lenses in non-presbyopic myopic eyes. Cont Lens Anterior Eye. 2016 Feb;39(1):38-46. doi: 10.1016/j.clae.2015.07.005. Epub 2015 Jul 27.
• Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44.
• Jaschinski W. The proximity-fixation-disparity curve and the preferred viewing distance at a visual display as an indicator of near vision fatigue. Optom Vis Sci. 2002 Mar;79(3):158-69.
• Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.
• Richdale K, Mitchell GL, Zadnik K. Comparison of multifocal and monovision soft contact lens corrections in patients with low-astigmatic presbyopia. Optom Vis Sci. 2006 May;83(5):266-73.
• Rouse MW, Borsting EJ, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R, Wensveen J; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in adults. Ophthalmic Physiol Opt. 2004 Sep;24(5):384-90.
• Rueff, Erin. Contact Lens Induced Dry Eye And Binocular Vision Disorders: A Study Of Similar Symptoms. (2014): Networked Digital Library of Theses & Dissertations. Oct. 2015.

• Responsible Party: Danielle Iacono, Assistant Clinical Professor, State University of New York College of Optometry
• ClinicalTrials.gov Identifier: NCT02921087
• Other Study ID Numbers: 923606
• First Posted: Sep 30, 2016
• Last Update Posted: Sep 11, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Asthenopia

Study Results

Participant Flow

Pre-assignment Detail	Forty five subjects were consented and screened. Twenty three were found to be eligible and randomized. Twenty two completed the study.

Arm/Group Title	Test 1 Week, Followed by Control 1 Week, no Washout	Control 1 Week, Followed by Test 1 Week, no Washout
Arm/Group Description	Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days	Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days
Period Title: Overall Study
STARTED	12	11
COMPLETED	12	10
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Test Followed by Control	Control Followed by Test	Total
Arm/Group Description	Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days	Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days	Total of all reporting groups
Overall Participants	12	11	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.83 (3.63)	25.09 (3.48)	27.04 (3.97)
Sex: Female, Male (Count of Participants)
Female	9 75%	10 90.9%	19 82.6%
Male	3 25%	1 9.1%	4 17.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	12 100%	11 100%	23 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 8.3%	0 0%	1 4.3%
Asian	2 16.7%	3 27.3%	5 21.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 8.3%	2 18.2%	3 13%
White	7 58.3%	5 45.5%	12 52.2%
More than one race	1 8.3%	1 9.1%	2 8.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	11 100%	23 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Symptom Improvement
Description	The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms).
Time Frame	Baseline and after 1 week of wearing each lens.

Outcome Measure Data

Analysis Population Description

Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. One week data for the primary outcome was available for 22 subjects.

Arm/Group Title	Test Arm: Multifocal Soft Contact Lenses	Control Arm: Single Vision Spherical Contact Lenses	Baseline Symptoms
Arm/Group Description	Symptoms after one week of wearing multifocal soft spherical contact lenses.	Symptoms after one week of wearing single vision soft spherical contact lenses.	Symptoms at visit one in habitual contact lenses
Measure Participants	22	22	22
Mean (Standard Deviation) [score on a scale]	153.9 (124.9)	100.7 (79.2)	272.13 (150.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
	Comments	In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Mixed Models Analysis
	Comments	Least-squares adjusted means were obtained and compared.

2. Secondary Outcome

Title	Lens Preference
Description	Based on two alternative forced choice method
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.

Arm/Group Title	Preferred Multifocal Lenses	Preferred Single Vision Lenses
Arm/Group Description	Percentage of subjects who preferred the multifocal (test) lenses	Percentage of subjects who preferred the single vision (control) lenses
Measure Participants	22	22
Count of Participants [Participants]	7 58.3%	15 136.4%

3. Secondary Outcome

Title	Lag of Accommodation in Study Lenses
Description	Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.

Arm/Group Title	Test Arm: Multifocal Soft Contact Lenses	Control Arm: Single Vision Spherical Contact Lenses
Arm/Group Description	Lag of Accommodation while wearing multifocal soft spherical contact lenses.	Lag of Accommodation while wearing single vision soft spherical contact lenses.
Measure Participants	22	22
Lag at 25 cm	1.52 (0.47)	1.23 (0.57)
Lag at 40 cm	1.06 (0.60)	0.75 (0.45)
Lag at Distance	0.00 (0.43)	0.22 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
	Comments	In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Mixed Models Analysis
	Comments	Least-squares adjusted means were obtained and compared.

4. Secondary Outcome

Title	Convergence Insufficiency Symptom Survey (CISS)
Description	Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.

Arm/Group Title	Test Arm: Multifocal Soft Contact Lenses	Control Arm: Single Vision Spherical Contact Lenses
Arm/Group Description	Symptoms after one week of wearing multifocal soft spherical contact lenses.	Symptoms after one week of wearing single vision soft spherical contact lenses.
Measure Participants	22	22
Mean (Standard Deviation) [score on a scale]	11.2 (6.8)	10.8 (5.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
	Comments	In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	Mixed Models Analysis
	Comments	Least-squares adjusted means were obtained and compared.

5. Secondary Outcome

Title	Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
Description	CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.

Arm/Group Title	Test Arm: Multifocal Soft Contact Lenses	Control Arm: Single Vision Spherical Contact Lenses
Arm/Group Description	Symptoms after one week of wearing multifocal soft spherical contact lenses.	Symptoms after one week of wearing single vision soft spherical contact lenses.
Measure Participants	22	22
Mean (Standard Deviation) [score on a scale]	11.7 (6.4)	11.0 (4.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
	Comments	In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Mixed Models Analysis
	Comments	Least-squares adjusted means were obtained and compared.

6. Secondary Outcome

Title	Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
Description	Measured via Modified Thorington
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.

Arm/Group Title	Test Arm: Multifocal Soft Contact Lenses	Control Arm: Single Vision Spherical Contact Lenses
Arm/Group Description	Near Phoria while wearing multifocal soft spherical contact lenses.	Near Phoria while wearing single vision soft spherical contact lenses.
Measure Participants	22	22
Mean (Standard Deviation) [Prism Diopters of Exophoria]	2.3 (3.8)	2.0 (4.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
	Comments	In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	Mixed Models Analysis
	Comments	Least-squares adjusted means were obtained and compared.

7. Post-Hoc Outcome

Title	Participants Stratified by Subjects' Near Phoria With Single Vision Lenses
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Phoria at near as measured through the single vision spherical contact lenses

Arm/Group Title	Phoria in Single Vision Spherical Contact Lenses
Arm/Group Description	Phoria at near as measured through the single vision spherical contact lenses
Measure Participants	22
Esophoria at Near	5 41.7%
Exophoria/ Orthophoria at Near	17 141.7%

8. Post-Hoc Outcome

Title	Phoria and Lens Preference
Description	Subjects' phoria at near with single vision lenses was classified as esophoric or exophoric. Lens preference was compared (multifocal vs single vision lenses) between the subjects who were esophoric at near vs the subjects who were exophoric/orthophoric at near.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Of the 22 completed subjects, 5 had an esophoria at near. 17 were exophoric or orthophoric at near.

Arm/Group Title	Esophoric at Near	Exophoric or Orthophoria at Near
Arm/Group Description	Subjects who are esophoric at near with single vision contact lenses	Subjects who were exophoric or orthophoric at near in single vision contact lenses
Measure Participants	5	17
Preferred Multifocal Contact Lenses	5 41.7%	2 18.2%
Preferred Single Vision Contact Lenses	0 0%	15 136.4%

Adverse Events

Time Frame	Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
Arm/Group Title	Multifocal Contact Lenses		Single Vision Contact Lenses
Arm/Group Description	Adverse Events while wearing Multifocal Contact Lenses		Adverse Events while wearing Single Vision Contact Lenses
All Cause Mortality
	Multifocal Contact Lenses		Single Vision Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/23 (0%)
Serious Adverse Events
	Multifocal Contact Lenses		Single Vision Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Multifocal Contact Lenses		Single Vision Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/22 (9.1%)		1/23 (4.3%)
Eye disorders
Conjunctival Hyperemia	0/22 (0%)	0	1/23 (4.3%)	2
Subcojnunctival Hemorrhage	1/22 (4.5%)	1	0/23 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cold Like Symptoms	1/22 (4.5%)	1	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.