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TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease (CVS)

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ClinicalTrials.gov Identifier: NCT00848198
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : April 14, 2016
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
TearLab Corporation

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Keratoconjunctivitis Sicca
Enrollment 314
Recruitment Details Subjects between the ages of 18 and 82 years were included in the study. Participants were chosen from 10 sites in the E.U. and U.S. from the general patient population. 314 total subjects were enrolled.
Pre-assignment Details Of the first 314 subjects enrolled, only 299 (n = 218 female, n = 81 male), were used in the analysis with the remainder disqualified for incomplete case report forms and lack of data from the single visit.
Arm/Group Title Total Number of Participants
Hide Arm/Group Description All participants who were tested using common signs and symptoms for dry eye disease
Period Title: Overall Study
Started 314
Completed 299
Not Completed 15
Reason Not Completed
Incomplete Case Report Forms             15
Arm/Group Title Total Number of Participants
Hide Arm/Group Description All participants who were tested using common signs and symptoms for dry eye disease
Overall Number of Baseline Participants 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants
<=18 years
0
   0.0%
Between 18 and 65 years
269
  85.7%
>=65 years
45
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants
46.3  (16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants
Female
233
  74.2%
Male
81
  25.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 314 participants
France 50
United States 139
Spain 50
Germany 50
United Kingdom 25
1.Primary Outcome
Title Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L
Hide Description

Tear osmolarity was measured with a laboratory-on-a-chip, to simultaneously collect and analyze the electrical impedance of a 50 nL tear sample from the interior lateral meniscus (TearLab Osmolarity System). A cutoff threshold of more than 308 mOsm/L was used for differentiating normal from mild to moderate subjects.

The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).

Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Presence of dry eye disease as defined by positive reference test
Absence of dry eye disease as defined by negative reference test
Overall Number of Participants Analyzed 224 75
Measure Type: Number
Unit of Measure: participants
Positive diagnostic test 177 14
Negative diagnostic test 47 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Dry Eye Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 87.1
Confidence Interval (2-Sided) 95%
83.2 to 90.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Without Dry Eye Disease (Normal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 72.0
Confidence Interval (2-Sided) 95%
66.9 to 77.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm
Hide Description

A 5-minute Schirmer test was performed with sterile strips without anesthetic (Tear Flo). The cutoff threshold of <7mm was used to differentiating normal from mild subjects.

The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).

Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Presence of dry eye disease as defined by positive reference test
Absence of dry eye disease as defined by negative reference test
Overall Number of Participants Analyzed 224 75
Measure Type: Number
Unit of Measure: participants
Positive diagnostic test 89 13
Negative diagnostic test 135 62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Dry Eye Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 39.7
Confidence Interval (2-Sided) 95%
34.2 to 45.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Without Dry Eye Disease (Normal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 82.7
Confidence Interval (2-Sided) 95%
78.4 to 87.0
Estimation Comments [Not Specified]
3.Primary Outcome
Title Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds
Hide Description Tear film breakup time was measured by instilling 5μL of a 2% sodium fluoresceine solution and calculating the average of three consecutive breakup times, manually determined with a stopwatch. The cutoff of <5 seconds was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, Meibomiann secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Presence of dry eye disease as defined by positive reference test
Absence of dry eye disease as defined by negative reference test
Overall Number of Participants Analyzed 224 75
Measure Type: Number
Unit of Measure: participants
Positive diagnostic test 161 13
Negative diagnostic test 63 62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Dry Eye Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 71.9
Confidence Interval (2-Sided) 95%
66.8 to 77.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Without Dry Eye Disease (Normal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 82.7
Confidence Interval (2-Sided) 95%
78.4 to 87.0
Estimation Comments [Not Specified]
4.Primary Outcome
Title Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15
Hide Description Corneal Staining was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Presence of dry eye disease as defined by positive reference test
Absence of dry eye disease as defined by negative reference test
Overall Number of Participants Analyzed 224 75
Measure Type: Number
Unit of Measure: participants
Positive diagnostic test 61 1
Negative diagnostic test 163 74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Dry Eye Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 27.2
Confidence Interval (2-Sided) 95%
22.2 to 32.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Without Dry Eye Disease (Normal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 98.7
Confidence Interval (2-Sided) 95%
97.4 to 100.0
Estimation Comments [Not Specified]
5.Primary Outcome
Title Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12
Hide Description Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Presence of dry eye disease as defined by positive reference test
Absence of dry eye disease as defined by negative reference test
Overall Number of Participants Analyzed 224 75
Measure Type: Number
Unit of Measure: participants
Positive diagnostic test 115 4
Negative diagnostic test 109 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Dry Eye Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 51.3
Confidence Interval (2-Sided) 95%
45.7 to 57.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Without Dry Eye Disease (Normal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 94.7
Confidence Interval (2-Sided) 95%
92.1 to 97.2
Estimation Comments [Not Specified]
6.Primary Outcome
Title Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27
Hide Description Meibomian dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A cutoff threshold of grade 5/27 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Presence of dry eye disease as defined by positive reference test
Absence of dry eye disease as defined by negative reference test
Overall Number of Participants Analyzed 224 75
Measure Type: Number
Unit of Measure: participants
Positive diagnostic test 137 16
Negative diagnostic test 87 59
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Dry Eye Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 61.2
Confidence Interval (2-Sided) 95%
55.6 to 66.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Without Dry Eye Disease (Normal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 78.7
Confidence Interval (2-Sided) 95%
74.0 to 83.3
Estimation Comments [Not Specified]
7.Primary Outcome
Title Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100
Hide Description Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Presence of dry eye disease as defined by positive reference test
Absence of dry eye disease as defined by negative reference test
Overall Number of Participants Analyzed 224 75
Measure Type: Number
Unit of Measure: participants
Positive diagnostic test 131 20
Negative diagnostic test 93 55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Dry Eye Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 58.5
Confidence Interval (2-Sided) 95%
52.9 to 64.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Without Dry Eye Disease (Normal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 73.3
Confidence Interval (2-Sided) 95%
68.3 to 78.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Referent Values for Tear Osmolarity
Hide Description [Not Specified]
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Severe Dry Eye Disease Participants With Mild/Moderate Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Subjects with composite severity score less than 0.20
Subjects with composite severity score between 0.20 and 0.35
Subjects with composite severity score greater than 0.35
Overall Number of Participants Analyzed 75 149 75
Mean (Standard Deviation)
Unit of Measure: mOsm/L
336.4  (22.3) 315.0  (11.4) 302.2  (8.3)
9.Secondary Outcome
Title Referent Values for Schirmer Test
Hide Description [Not Specified]
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Severe Dry Eye Disease Participants With Mild/Moderate Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Subjects with composite severity score less than 0.20
Subjects with composite severity score between 0.20 and 0.35
Subjects with composite severity score greater than 0.35
Overall Number of Participants Analyzed 75 149 75
Mean (Standard Deviation)
Unit of Measure: mm
8.2  (8.4) 13.9  (9.5) 19.3  (10.4)
10.Secondary Outcome
Title Referent Values for Tear Film Breakup Time
Hide Description [Not Specified]
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Severe Dry Eye Disease Participants With Mild/Moderate Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Subjects with composite severity score less than 0.20
Subjects with composite severity score between 0.20 and 0.35
Subjects with composite severity score greater than 0.35
Overall Number of Participants Analyzed 75 149 75
Mean (Standard Deviation)
Unit of Measure: seconds
2.7  (1.5) 6.1  (4.9) 11.8  (6.4)
11.Secondary Outcome
Title Referent Values for Corneal Staining
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Severe Dry Eye Disease Participants With Mild/Moderate Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Subjects with composite severity score less than 0.20
Subjects with composite severity score between 0.20 and 0.35
Subjects with composite severity score greater than 0.35
Overall Number of Participants Analyzed 75 149 75
Mean (Standard Deviation)
Unit of Measure: Grade
5.1  (4.1) 1.7  (1.9) 0.4  (0.9)
12.Secondary Outcome
Title Referent Values for Conjunctival Staining
Hide Description Conjunctival staining is used to identify and evaluate dead or injured conjunctival cells. Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. A score of 0 indicates no damage of conjunctival cells, while the maximum for the most severe damage is 12.
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Severe Dry Eye Disease Participants With Mild/Moderate Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Subjects with composite severity score less than 0.20
Subjects with composite severity score between 0.20 and 0.35
Subjects with composite severity score greater than 0.35
Overall Number of Participants Analyzed 75 149 75
Mean (Standard Deviation)
Unit of Measure: Grade
5.9  (3.6) 2.6  (1.9) 1.1  (1.4)
13.Secondary Outcome
Title Referent Values for Meibomian Gland Grading
Hide Description Meibomian gland dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A score of 0 indicates full integrity of these glands while the maximum of 27, is used for severe damage.
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Severe Dry Eye Disease Participants With Mild/Moderate Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Subjects with composite severity score less than 0.20
Subjects with composite severity score between 0.20 and 0.35
Subjects with composite severity score greater than 0.35
Overall Number of Participants Analyzed 75 149 75
Mean (Standard Deviation)
Unit of Measure: Grade
10.4  (5.2) 5.6  (4.7) 2.6  (2.7)
14.Secondary Outcome
Title Referent Values for Ocular Surface Disease Index
Hide Description Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment and the index is calculated based on the responses given by the subject. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. A score of 0 confirms no dry eye symptoms are present, while a maximum of 100 indicates the maximum severity of symptoms experienced by subjects.
Time Frame Single visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Severe Dry Eye Disease Participants With Mild/Moderate Dry Eye Disease Participants Without Dry Eye Disease (Normal)
Hide Arm/Group Description:
Subjects with composite severity score less than 0.20
Subjects with composite severity score between 0.20 and 0.35
Subjects with composite severity score greater than 0.35
Overall Number of Participants Analyzed 75 149 75
Mean (Standard Deviation)
Unit of Measure: Score
41.2  (21.6) 21.0  (19.2) 5.5  (7.4)
Time Frame Time of the single visit
Adverse Event Reporting Description No side effects were reported or observed.
 
Arm/Group Title Total Number of Participants
Hide Arm/Group Description All participants who were tested using common signs and symptoms for dry eye disease
All-Cause Mortality
Total Number of Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Number of Participants
Affected / at Risk (%)
Total   0/314 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Number of Participants
Affected / at Risk (%)
Total   0/314 (0.00%) 
95/299 subjects were using topical medication at the time of measurement, potentially lowering the diagnostic performance of osmolarity (osmolarity is lowered and responds before the other tests during therapy) and compressing the referent spread.
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.
Results Point of Contact
Name/Title: Michael Berg, VP of Regulatory
Organization: TearLab, Inc.
Phone: 858-795-6887
Responsible Party: TearLab Corporation
ClinicalTrials.gov Identifier: NCT00848198     History of Changes
Other Study ID Numbers: TP00007 OTO
First Submitted: February 18, 2009
First Posted: February 20, 2009
Results First Submitted: April 5, 2011
Results First Posted: April 14, 2016
Last Update Posted: May 16, 2016