DREAM: Dry Eye Assessment and Management Study

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02128763
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 535
• Locations: 27
• Arms: 2
• Duration (Months): 63
• Patients Per Site: 19.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Omega-3 supplements; Drug: Placebo	Phase 3

Detailed Description

The study is designed to:

• Test the hypothesis that omega-3 supplementation is an effective treatment for Dry Eye Disease (DED) in Primary Clinical Trial.

• Better understand DED by describing and evaluating a comprehensive set of features of DED and treatment over 12 months of observation in a well-characterized group of patients.

• Determine the effects of extended use and discontinuation of omega-3 through the Extension trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 535 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dry Eye Assessment and Management Study
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Sep 5, 2017
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omega-3 supplements Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps	Drug: Omega-3 supplements; 2000 mg EPA and 1000 mg DHA per day
Placebo Comparator: Placebo Olive oil-5 gelcaps per day	Drug: Placebo; Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Outcome Measures

Primary Outcome Measures

1. Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months [12 months]

   Average of Ocular Surface Disease Index (OSDI) scores from 6 and 12 months minus average of values from screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points.

Secondary Outcome Measures

1. Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) [12 months]

   Number of participants with at least a 10 point decrease from baseline in Ocular Surface Disease Index (OSDI). Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. A negative change score = improvement.

2. Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale [12 months]

   Brief Ocular Discomfort Index (BODI) Pain Interference subscale scores range from 0 to 100, with higher scores indicating greater discomfort. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A negative change score = improvement.

3. Change From Baseline in SF-36 Physical Health Subscale [12 months]

   Medical Outcomes Study 36--Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self reported physical health-related quality of life. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.

4. Change From Baseline in SF-36 Mental Health Subscale [12 months]

   Medical Outcomes Study 26--Item Short Form Health Survey (SF-36) Mental Health Subscale. Mental Health subscale range is 0-100 with higher scores indicating better self reported mental health. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.

5. Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA [12 months]

   Change in EPA levels in red blood cells - percentage points. Change is the average level at 6 and 12 months minus the level at the eligibility confirmation visit. (Blood was not drawn at the screening visit.) If subjects are compliant, higher EPA levels in red blood cells in the Omega 3 group are expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn at the visit.

6. Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA [12 months]

   Change in DHA levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit (blood was not drawn at the screening visit. If compliant, higher DHA levels in red blood cells in the Omega 3 group is expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.

7. Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid [12 months]

   Change in Oleic Acid (from olive oil) levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit. (Blood was not drawn at the screening visit.) Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn.

8. Change in Conjunctival Staining Score [12 months]

   Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. Scores range between 0-6, with higher scores indicate more severity. A negative change indicates improvement.

9. Change in Schirmer's Test mm [12 months]

   The Schirmer's test measures the production of tears by an eye as measured by mm of wetting of a strip of paper attached to the lower lid for 5 minutes. Scores range from 0 to 30 or more mm. Lower scores indicate more severe dry eye. Change is the average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study.

10. Change in Tear Film Break up Time, in Seconds [12 months]

    Average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Possible range of scores is 0->20. Low values indicate greater severity. A positive change score = improvement.

11. Change in Corneal Fluorescein Staining Score [12 months]

    Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severity. A negative change indicates improvement.

12. Change in Visual Acuity [12 months]

    Visual acuity scores of 0-100 correspond to Snellen visual acuity levels of worse than 20/800 to 20/10, respectively. Higher change score = improved visual acuity.

13. Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease [12 months]

    Subjects with change in number of treatments used for dry eye disease, n.,(%)

Other Outcome Measures

1. Change in Intraocular Pressure (IOP)- mm Hg [12 months]

   Eye pressure is measured in millimeters of mercury (mm Hg). Normal eye pressure ranges from 12-22 mm Hg, and eye pressure of greater than 22 mm Hg is considered higher than normal. Included as a safety measure.

2. Change in Tear Break up Time by Keratography [12 months]

   Tear breakup time (TBUT) is used to assess for evaporative dry eye disease. In this measure, TBUT is measured using the keratograph machine. TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.

3. Change in Tear Meniscus Height( TMH) by Keratography [12 months]

   The purpose of the tear film is to reduce evaporation of natural tears. Assessment of the tear film meniscus is a quantitative measurement of tear film quantity. In this measure, TMH is measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.

4. Change in Redness by Keratography [12 months]

   Change in ocular redness as measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Title of the Scale used to measure outcome: Oculus Keratograph 5M R-scan, Scale Ranges: 0.0-4.0. A lower number indicates a better outcome (less redness).

5. Change in Tear Osmolarity [12 months]

   Tear osmolarity measures the salt content of the tears. Higher the osmolarity indicate more severe dry eye. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. A lower change score indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.

• Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.

• Symptoms of DED for greater than or equal to 6 months.

• Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks.

• Ability to swallow large, soft gelcaps

Exclusion Criteria:

• Allergic to ingredients in supplements or placebo

• Contact lens wear

• Pregnant, nursing, or lactating

• Current ocular infection, inflammation, or acute allergic conjunctivitis

• History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies

• Currently on anticoagulation therapy

• Eyelid abnormalities or extensive ocular scarring

• Use of EPA/DHA supplements in excess of 1200 mg per dayi

• Current use, insufficient washout period, or intent to change specific treatments for dry eye disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stephen Cohen, OD PC	Scottsdale	Arizona	United States	85254
2	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259
3	Milton M. Hom, OD, FAAO	Azusa	California	United States	91702
4	University of California, Berkeley	Berkeley	California	United States	94720
5	Pendleton Eye Center	Oceanside	California	United States	92056
6	Wolstan and Goldberg Eye Associates	Torrance	California	United States	90505
7	Shettle Eye Research	Largo	Florida	United States
8	Eye Care Centers Management, Inc.	Morrow	Georgia	United States	30260
9	University of Illinois Hospital & Health Sciences	Chicago	Illinois	United States	60612
10	Price Vision Group	Indianapolis	Indiana	United States	46260
11	KU Eye Center	Prairie Village	Kansas	United States	66208
12	Tufts Medical Center	Boston	Massachusetts	United States	02111
13	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States	02114
14	Clinical Eye Research of Boston	Winchester	Massachusetts	United States	01890
15	University of Michigan Kellogg Eye Center	Ann Arbor	Michigan	United States	48105
16	Minnesota Eye Consultants, P.A.	Bloomington	Minnesota	United States	55431
17	Mulqueeny Eye Centers	Creve Coeur	Missouri	United States	63141
18	Tauber Eye Center	Kansas City	Missouri	United States	64111
19	Silverstein Eye Centers	Kansas City	Missouri	United States	64133
20	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
21	Universtity of Rochester-Flaum Eye Institute	Rochester	New York	United States	14642
22	Oculus Research at Garner at Eyecarecenter	Raleigh	North Carolina	United States	27603
23	Case Western Reserve University	Cleveland	Ohio	United States	44106
24	Northeast Ohio Eye Surgeons	Kent	Ohio	United States	44240
25	Scheie Eye Institute, University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
26	Southern College of Optometry	Memphis	Tennessee	United States	38104
27	The Eye Centers of Racine and Kenosha	Racine	Wisconsin	United States	53405

Sponsors and Collaborators

• University of Pennsylvania
• National Eye Institute (NEI)

Investigators

• Study Chair: Penny A Asbell, MD, University of Tennessee Health Science Center
• Principal Investigator: Maureen G Maguire, PhD, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 1, 2017

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02128763
• Other Study ID Numbers: UPenn IRB Protocol 816490; U10EY022879; U10EY022881
• First Posted: May 1, 2014
• Last Update Posted: Jul 19, 2022
• Last Verified: Jun 1, 2022

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

Participant Flow

Arm/Group Title	Omega-3 Supplements	Placebo
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day containing a total of 5 grams of refined olive oil Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Period Title: Overall Study
STARTED	349	186
COMPLETED	329	170
NOT COMPLETED	20	16

Baseline Characteristics

Arm/Group Title	Omega-3 Supplements	Placebo	Total
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps	Total of all reporting groups
Overall Participants	349	186	535
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.3 (13.5)	57.5 (12.6)	58.0 (13.2)
Sex: Female, Male (Count of Participants)
Female	284 81.4%	150 80.6%	434 81.1%
Male	65 18.6%	36 19.4%	101 18.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	44 12.6%	24 12.9%	68 12.7%
Not Hispanic or Latino	302 86.5%	161 86.6%	463 86.5%
Unknown or Not Reported	3 0.9%	1 0.5%	4 0.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.6%	1 0.5%	3 0.6%
Asian	12 3.4%	7 3.8%	19 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	39 11.2%	25 13.4%	64 12%
White	265 75.9%	133 71.5%	398 74.4%
More than one race	4 1.1%	5 2.7%	9 1.7%
Unknown or Not Reported	27 7.7%	15 8.1%	42 7.9%
Region of Enrollment (participants) [Number]
United States	349 100%	186 100%	535 100%
OSDI Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.6 (14.1)	44.1 (14.6)	44.1 (14.2)
Brief Ocular Discomfort Inventory (BODI) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	33.2 (15.5)	33.4 (16.3)	33.2 (15.8)
EPA level in red cells (percentage of total fatty acids) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of total fatty acids]	0.63 (0.43)	0.56 (0.35)	0.60 (0.40)
DHA level in red blood cells at baseline (percentage of total fatty acids) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of total fatty acids]	3.91 (1.17)	3.85 (1.11)	3.9 (1.1)
Oleic Acid (OA) level in red cells (percentage of total fatty acids) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of total fatty acids]	11.11 (1.24)	11.10 (1.38)	11.1 (1.3)
Tear Break Up Time (TBUT) (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	3.1 (1.4)	3.1 (1.6)	3.1 (1.5)
Schimer's Test (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	9.3 (6.2)	10.2 (7.0)	9.8 (7.2)
Conjunctival Staining (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.1 (1.4)	2.9 (1.4)	3.0 (1.4)
Corneal Staining (point score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [point score]	4.0 (2.9)	3.7 (2.4)	3.9 (2.7)

Outcome Measures

1. Primary Outcome

Title	Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months
Description	Average of Ocular Surface Disease Index (OSDI) scores from 6 and 12 months minus average of values from screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Mean (Standard Deviation) [units on a scale]	-13.9 (15.6)	-12.5 (18.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.40
	Comments	P value refers to difference between group on change in overall OSDI score (Row 1).
	Method	Regression, Linear
	Comments

2. Secondary Outcome

Title	Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)
Description	Number of participants with at least a 10 point decrease from baseline in Ocular Surface Disease Index (OSDI). Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. A negative change score = improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day (5 gms of refined olive oil/day) Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Count of Participants [Participants]	202 57.9%	91 48.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

Title	Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale
Description	Brief Ocular Discomfort Index (BODI) Pain Interference subscale scores range from 0 to 100, with higher scores indicating greater discomfort. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A negative change score = improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Mean (Standard Deviation) [score on a scale]	-9.4 (15.0)	-8.9 (16.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	Regression, Linear
	Comments	Pos hoc application of the Benjamini-Hochberg adjustment

4. Secondary Outcome

Title	Change From Baseline in SF-36 Physical Health Subscale
Description	Medical Outcomes Study 36--Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self reported physical health-related quality of life. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day (5 gms of refined olive oil/day) Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Mean (Standard Deviation) [score on a scale]	0.1 (6.9)	0.1 (6.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	Regression, Linear
	Comments

5. Secondary Outcome

Title	Change From Baseline in SF-36 Mental Health Subscale
Description	Medical Outcomes Study 26--Item Short Form Health Survey (SF-36) Mental Health Subscale. Mental Health subscale range is 0-100 with higher scores indicating better self reported mental health. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Mean (Standard Deviation) [score on a scale]	-0.9 (6.3)	0.4 (7.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	Regression, Linear
	Comments

6. Secondary Outcome

Title	Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA
Description	Change in EPA levels in red blood cells - percentage points. Change is the average level at 6 and 12 months minus the level at the eligibility confirmation visit. (Blood was not drawn at the screening visit.) If subjects are compliant, higher EPA levels in red blood cells in the Omega 3 group are expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn at the visit.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	309	155
Mean (Standard Deviation) [percentage of fatty acids in blood cells]	2.2 (1.2)	0.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments

7. Secondary Outcome

Title	Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA
Description	Change in DHA levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit (blood was not drawn at the screening visit. If compliant, higher DHA levels in red blood cells in the Omega 3 group is expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	309	155
Mean (Standard Deviation) [percentage of fatty acids in blood cells]	1.6 (1.2)	0.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments

8. Secondary Outcome

Title	Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid
Description	Change in Oleic Acid (from olive oil) levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit. (Blood was not drawn at the screening visit.) Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	309	155
Mean (Standard Deviation) [percentage of oleic acid in blood cells]	-0.1 (1.0)	-0.1 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	Method	Regression, Linear
	Comments

9. Secondary Outcome

Title	Change in Conjunctival Staining Score
Description	Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. Scores range between 0-6, with higher scores indicate more severity. A negative change indicates improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Among eyes that qualified for the study.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Measure eyes	629	327
Mean (Standard Deviation) [units on a scale]	-0.4 (1.1)	-0.4 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	Regression, Linear
	Comments

10. Secondary Outcome

Title	Change in Schirmer's Test mm
Description	The Schirmer's test measures the production of tears by an eye as measured by mm of wetting of a strip of paper attached to the lower lid for 5 minutes. Scores range from 0 to 30 or more mm. Lower scores indicate more severe dry eye. Change is the average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

among eligible eyes

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Measure eyes	629	327
Mean (Standard Deviation) [mm]	0.4 (5.3)	0.3 (5.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	Regression, Linear
	Comments

11. Secondary Outcome

Title	Change in Tear Film Break up Time, in Seconds
Description	Average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Possible range of scores is 0->20. Low values indicate greater severity. A positive change score = improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Measure is eyes, not people.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Measure eyes	629	327
Mean (Standard Deviation) [seconds]	0.7 (2.1)	0.6 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Regression, Linear
	Comments

12. Secondary Outcome

Title	Change in Corneal Fluorescein Staining Score
Description	Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severity. A negative change indicates improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Measure eyes	629	327
Mean (Standard Deviation) [units on a scale]	-0.6 (1.9)	-0.7 (1.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	Regression, Linear
	Comments

13. Secondary Outcome

Title	Change in Visual Acuity
Description	Visual acuity scores of 0-100 correspond to Snellen visual acuity levels of worse than 20/800 to 20/10, respectively. Higher change score = improved visual acuity.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Each eye measured separately. Total are numbers of eyes assessed, not subjects.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Measure eyes	656	340
Mean (Standard Deviation) [score on a scale]	-0.5 (5.0)	-0.2 (4.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Regression, Linear
	Comments

14. Secondary Outcome

Title	Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease
Description	Subjects with change in number of treatments used for dry eye disease, n.,(%)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data are missing for 5 subjects in the omega -3 group and 6 subjects in the placebo group

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms of Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	324	164
Fewer treatments used, with no additions	171 49%	93 50%
No Change	80 22.9%	36 19.4%
≤ treatments used, with ≥1 treatment switched	40 11.5%	23 12.4%
More treatments used	33 9.5%	12 6.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Chi-squared, Corrected
	Comments

15. Other Pre-specified Outcome

Title	Change in Intraocular Pressure (IOP)- mm Hg
Description	Eye pressure is measured in millimeters of mercury (mm Hg). Normal eye pressure ranges from 12-22 mm Hg, and eye pressure of greater than 22 mm Hg is considered higher than normal. Included as a safety measure.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Each eye measured separately

Arm/Group Title	Omega-3 Supplements	Placebo
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	329	170
Measure eyes	658	340
Mean (Standard Deviation) [mmHg]	0.0 (2.3)	0.3 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Regression, Linear
	Comments

16. Other Pre-specified Outcome

Title	Change in Tear Break up Time by Keratography
Description	Tear breakup time (TBUT) is used to assess for evaporative dry eye disease. In this measure, TBUT is measured using the keratograph machine. TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Each eye is measured separately. Total are number of eyes assessed, not subjects. Tear Break up Time by Keratography was only measured at the 13 clinical centers that owned an Oculus Keratograph machine; therefore the number of participants analyzed for this measure is less than the overall number of study participants.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	154	80
Measure eyes	290	149
Mean (Standard Deviation) [seconds]	-0.5 (6.7)	-0.5 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Regression, Linear
	Comments

17. Other Pre-specified Outcome

Title	Change in Tear Meniscus Height( TMH) by Keratography
Description	The purpose of the tear film is to reduce evaporation of natural tears. Assessment of the tear film meniscus is a quantitative measurement of tear film quantity. In this measure, TMH is measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Each eye measured separately. Total are number of eyes assessed, not subjects. Tear Meniscus Height by Keratography was only measured at the 13 clinical centers that owned an Oculus Keratograph machine; therefore, the number of participants analyzed for this measure is less than the overall number of study participants.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	167	87
Measure eyes	317	162
Mean (Standard Deviation) [mm]	0.00 (0.16)	-0.01 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	Regression, Linear
	Comments

18. Other Pre-specified Outcome

Title	Change in Redness by Keratography
Description	Change in ocular redness as measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Title of the Scale used to measure outcome: Oculus Keratograph 5M R-scan, Scale Ranges: 0.0-4.0. A lower number indicates a better outcome (less redness).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Each eye measured separately. Total are number of eyes assessed, not subjects. Change in redness measured by keratography was only performed at the 13 clinical centers that owned an Oculus Keratograph machine; therefore, the number of participants analyzed for this measure is less than the overall number of study participants.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	150	80
Measure eyes	273	145
Mean (Standard Deviation) [score on a scale]	-0.00 (0.34)	-0.01 (0.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	Regression, Linear
	Comments

19. Other Pre-specified Outcome

Title	Change in Tear Osmolarity
Description	Tear osmolarity measures the salt content of the tears. Higher the osmolarity indicate more severe dry eye. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. A lower change score indicates improvement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Each eye is measured separately. Total are number of eyes assessed, not subjects.Tear Osmolarity was only performed at the 18 clinical centers that owned a Tearlab osmolarity machine; therefore the number of participants analyzed for this measure is less than the overall number of study participants.

Arm/Group Title	Omega-3 Supplements	Placebo (5 Gms Refined Olive Oil/Day)
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day	Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Measure Participants	233	117
Measure eyes	424	212
Mean (Standard Deviation) [mOsms/L]	-0.7 (21.5)	3.6 (18.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Regression, Linear
	Comments

Adverse Events

Time Frame	AE data were collected from the safety visit to 12 months The AE reporting period was the from the screening visit to the end of the study follow-up (12 months). At the last visit, subjects were instructed to report any subsequent event(s) occurring within 30 days that the subject or a physician, believed might reasonably be related to study treatment. Subjects who withdrew early were contacted by the Clinic Coordinator 30 days after their last visit to ascertain whether any AEs occurred.
Arm/Group Title	Omega-3 Supplements		Placebo
Arm/Group Description	Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day		Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
All Cause Mortality
	Omega-3 Supplements		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/349 (0.3%)		0/186 (0%)
Serious Adverse Events
	Omega-3 Supplements		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/349 (6%)		15/186 (8.1%)
Cardiac disorders
ATRIAL FIBRILLATION	1/349 (0.3%)	1	1/186 (0.5%)	1
ATRIAL FLUTTER	1/349 (0.3%)	1	0/186 (0%)	0
Gastrointestinal disorders
COLITIS	1/349 (0.3%)	1	0/186 (0%)	0
COLONIC OBSTRUCTION	1/349 (0.3%)	1	0/186 (0%)	0
DYSPEPSIA	1/349 (0.3%)	1	0/186 (0%)	0
Hepatobiliary disorders
GALLBLADER PAIN	0/349 (0%)	0	1/186 (0.5%)	1
Immune system disorders
HYPERSENSITIVITY	1/349 (0.3%)	1	0/186 (0%)	0
Infections and infestations
ABDOMINAL INFECTION	1/349 (0.3%)	1	0/186 (0%)	0
OSTEOMYELITIS	0/349 (0%)	0	1/186 (0.5%)	1
SKIN INFECTION	0/349 (0%)	0	1/186 (0.5%)	1
Injury, poisoning and procedural complications
FALL	1/349 (0.3%)	1	0/186 (0%)	0
HIP FRACTURE	1/349 (0.3%)	1	0/186 (0%)	0
SUBDURAL HAEMATOMA	0/349 (0%)	0	1/186 (0.5%)	1
Musculoskeletal and connective tissue disorders
CHONDROCALCINOSIS PYROPHOSPHATE	0/349 (0%)	0	1/186 (0.5%)	1
NECK PAIN	1/349 (0.3%)	1	0/186 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER	0/349 (0%)	0	1/186 (0.5%)	1
CHRONIC MYELOID LEUKAEMIA	1/349 (0.3%)	1	0/186 (0%)	0
LYMPHOMA	1/349 (0.3%)	1	1/186 (0.5%)	1
MALIGNANT MELANOMA	1/349 (0.3%)	1	0/186 (0%)	0
SQUAMOUS CELL CARCINOMA	1/349 (0.3%)	1	0/186 (0%)	0
Nervous system disorders
FACIAL PALSY	0/349 (0%)	0	1/186 (0.5%)	1
Psychiatric disorders
PSYCHOTIC DISORDER	1/349 (0.3%)	2	0/186 (0%)	0
Renal and urinary disorders
HYDRONEPHROSIS	1/349 (0.3%)	1	0/186 (0%)	0
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION	1/349 (0.3%)	1	0/186 (0%)	0
PNEUMOTHORAX	1/349 (0.3%)	1	0/186 (0%)	0
PULMONARY EMBOLISM	1/349 (0.3%)	1	0/186 (0%)	0
Surgical and medical procedures
ARTHRODESIS	0/349 (0%)	0	1/186 (0.5%)	1
CHOLECYSTECTOMY	0/349 (0%)	0	2/186 (1.1%)	2
COLECTOMY	1/349 (0.3%)	1	0/186 (0%)	0
GASTROINTESTINAL ENDOSCOPIC THERAPY	1/349 (0.3%)	1	0/186 (0%)	0
HYSTERECTOMY	1/349 (0.3%)	1	0/186 (0%)	0
KNEE ARTHROPLASTY	1/349 (0.3%)	1	1/186 (0.5%)	1
OVARIAN CYSTECTOMY	1/349 (0.3%)	1	0/186 (0%)	0
PARATHYROIDECTOMY	0/349 (0%)	0	1/186 (0.5%)	1
Vascular disorders
DEEP VEIN THROMBOSIS	0/349 (0%)	0	1/186 (0.5%)	1
HYPERTENSION	1/349 (0.3%)	1	0/186 (0%)	0
Other (Not Including Serious) Adverse Events
	Omega-3 Supplements		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/349 (0%)		0/186 (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.