Keratoconjunctivitis Sicca
Conditions
Keywords
Dry Eye Disease, Dry Eye Syndrome, Dry Eye
Brief summary
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.
Detailed description
This is a prospective, observational case series to determine the clinical utility of tear osmolarity, tear film breakup time, corneal fluorescein staining, conjunctival lissamine green staining, Schirmer's test without anesthesia, Bron/Foulks meibomian glan grading and the ocular surface disease index to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease. Patients were recruited across sites in the EU and US from the general clinical population.
Interventions
None listed
Sponsors
Alcon Research
TearLab Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between the ages of 18 and 79 years of age. * Must understand and be able, willing and likely to fully comply with study procedures and restrictions.
Exclusion criteria
* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.. * Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for Dry Eye Disease, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring. * Active ocular allergy. * LASIK or PRK surgery that was performed within one year of Visit 1. * Started or changed the dose of chronic ocular medication within 30 days of visit 1. * Contact lens worn within the past eight (8) hours. * Any ophthalmologic drops within 2 hours of screening and visit 1 procedures. * Pregnancy or lactation. * Abnormality of nasolacrimal drainage (by history). * Punctual plugs placement or cauterization within 30 days of Visit 1 * Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Visit 1. * Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1. * Known hypersensitivity to any of the agents used in testing i.e. sodium fluorescein, lissamine green, oxybuprocaine or proparacaine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 | Single visit | 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). |
| Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L | Single visit | 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). |
| Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm | Single visit | 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). |
| Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds | Single visit | 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). |
| Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 | Single visit | 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). |
| Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 | Single visit | 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). |
| Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 | Single visit | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Referent Values for Tear Film Breakup Time | Single visit | — |
| Referent Values for Tear Osmolarity | Single visit | — |
| Referent Values for Schirmer Test | Single visit | — |
| Referent Values for Corneal Staining | Single visit | Corneal Staining is used to identify and evaluate ocular surface and corneal damages. It 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. A score of 0 indicates no damage of ocular surface/cornea, while the maximum for the most severe damage is 15. |
| Referent Values for Conjunctival Staining | Single visit | 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. |
| Referent Values for Meibomian Gland Grading | Single visit | 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. |
| Referent Values for Ocular Surface Disease Index | Single visit | 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. |
Countries
France, Germany, Spain, United Kingdom, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Total Number of Participants All participants who were tested using common signs and symptoms for dry eye disease | 314 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Incomplete Case Report Forms | 15 |
Baseline characteristics
| Characteristic | Total Number of Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 45 Participants |
| Age, Categorical Between 18 and 65 years | 269 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 16.9 |
| Region of Enrollment France | 50 participants |
| Region of Enrollment Germany | 50 participants |
| Region of Enrollment Spain | 50 participants |
| Region of Enrollment United Kingdom | 25 participants |
| Region of Enrollment United States | 139 participants |
| Sex: Female, Male Female | 233 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 314 |
| serious Total, serious adverse events | 0 / 314 |
Outcome results
Primary
Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 | Positive diagnostic test | 115 participants |
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 | Negative diagnostic test | 109 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 | Positive diagnostic test | 4 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 | Negative diagnostic test | 71 participants |
95% CI: [45.7, 57]
95% CI: [92.1, 97.2]
Primary
Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 | Positive diagnostic test | 61 participants |
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 | Negative diagnostic test | 163 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 | Positive diagnostic test | 1 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 | Negative diagnostic test | 74 participants |
95% CI: [22.2, 32.3]
95% CI: [97.4, 100]
Primary
Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 | Positive diagnostic test | 137 participants |
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 | Negative diagnostic test | 87 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 | Positive diagnostic test | 16 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 | Negative diagnostic test | 59 participants |
95% CI: [55.6, 66.7]
95% CI: [74, 83.3]
Primary
Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 | Positive diagnostic test | 131 participants |
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 | Negative diagnostic test | 93 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 | Positive diagnostic test | 20 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 | Negative diagnostic test | 55 participants |
95% CI: [52.9, 64.1]
95% CI: [68.3, 78.3]
Primary
Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm | Positive diagnostic test | 89 participants |
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm | Negative diagnostic test | 135 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm | Positive diagnostic test | 13 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm | Negative diagnostic test | 62 participants |
95% CI: [34.2, 45.3]
95% CI: [78.4, 87]
Primary
Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds | Positive diagnostic test | 161 participants |
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds | Negative diagnostic test | 63 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds | Positive diagnostic test | 13 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds | Negative diagnostic test | 62 participants |
95% CI: [66.8, 77]
95% CI: [78.4, 87]
Primary
Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L | Positive diagnostic test | 177 participants |
| Participants With Dry Eye Disease | Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L | Negative diagnostic test | 47 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L | Positive diagnostic test | 14 participants |
| Participants Without Dry Eye Disease (Normal) | Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L | Negative diagnostic test | 61 participants |
95% CI: [83.2, 90.9]
95% CI: [66.9, 77.1]
Secondary
Referent Values for Conjunctival Staining
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Dry Eye Disease | Referent Values for Conjunctival Staining | 5.9 Grade | Standard Deviation 3.6 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Conjunctival Staining | 2.6 Grade | Standard Deviation 1.9 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Conjunctival Staining | 1.1 Grade | Standard Deviation 1.4 |
Secondary
Referent Values for Corneal Staining
Corneal Staining is used to identify and evaluate ocular surface and corneal damages. It 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. A score of 0 indicates no damage of ocular surface/cornea, while the maximum for the most severe damage is 15.
Time frame: Single visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Dry Eye Disease | Referent Values for Corneal Staining | 5.1 Grade | Standard Deviation 4.1 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Corneal Staining | 1.7 Grade | Standard Deviation 1.9 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Corneal Staining | 0.4 Grade | Standard Deviation 0.9 |
Secondary
Referent Values for Meibomian Gland Grading
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Dry Eye Disease | Referent Values for Meibomian Gland Grading | 10.4 Grade | Standard Deviation 5.2 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Meibomian Gland Grading | 5.6 Grade | Standard Deviation 4.7 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Meibomian Gland Grading | 2.6 Grade | Standard Deviation 2.7 |
Secondary
Referent Values for Ocular Surface Disease Index
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Dry Eye Disease | Referent Values for Ocular Surface Disease Index | 41.2 Score | Standard Deviation 21.6 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Ocular Surface Disease Index | 21.0 Score | Standard Deviation 19.2 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Ocular Surface Disease Index | 5.5 Score | Standard Deviation 7.4 |
Secondary
Referent Values for Schirmer Test
Time frame: Single visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Dry Eye Disease | Referent Values for Schirmer Test | 8.2 mm | Standard Deviation 8.4 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Schirmer Test | 13.9 mm | Standard Deviation 9.5 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Schirmer Test | 19.3 mm | Standard Deviation 10.4 |
Secondary
Referent Values for Tear Film Breakup Time
Time frame: Single visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Dry Eye Disease | Referent Values for Tear Film Breakup Time | 2.7 seconds | Standard Deviation 1.5 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Tear Film Breakup Time | 6.1 seconds | Standard Deviation 4.9 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Tear Film Breakup Time | 11.8 seconds | Standard Deviation 6.4 |
Secondary
Referent Values for Tear Osmolarity
Time frame: Single visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Dry Eye Disease | Referent Values for Tear Osmolarity | 336.4 mOsm/L | Standard Deviation 22.3 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Tear Osmolarity | 315.0 mOsm/L | Standard Deviation 11.4 |
| Participants Without Dry Eye Disease (Normal) | Referent Values for Tear Osmolarity | 302.2 mOsm/L | Standard Deviation 8.3 |