Chronic Ocular Graft-versus-host Disease
Conditions
Brief summary
To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.
Detailed description
Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients. A controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill. Potential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life.
Interventions
Topical gel for forehead dermal application
Topical gel for forehead dermal application
Sponsors
ORA, Inc.
Glia, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomized double-masked parallel treatment assignment will be made using a block design at the ratio of 2:1, study drug:placebo, (22 subjects:11 subjects). This 70-day double-masked phase will be followed by 6 weeks open-label active drug treatment of the subjects previously on placebo.
Intervention model description
The double-masked phase involves placebo controlled administration of study drug for 70 days or 10 weeks. Subsequently the placebo group will receive the active study drug of 42 days or 6 weeks. Long term open label phase to 27 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female of any race, at least 18 years of age at Visit 1 Screening. 2. Has the diagnosis of chronic ocular GvHD. 3. Has an NIH Consensus Eye Score of at least 2. 4. On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more. 5. One or more signs from the list of chronic ocular GvHD signs below 6. Has provided verbal and written informed consent. 7. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.
Exclusion criteria
1. Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study. 2. Anticipate major changes in systemic GvHD management during study period. 3. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia. 4. Anticipate change of vision correction or anticipate any ocular procedures during study period. 5. A woman who is pregnant, nursing an infant, or planning a pregnancy. 6. A woman of childbearing potential who has a positive urine pregnancy test at Visit 1, or who does not use an adequate method of birth control throughout the study period. 7. Has a known adverse reaction and/or sensitivity to the study drug or its components. 8. Unwilling to cease the use of sunscreen on the forehead or eye area. 9. Intraocular pressure \>22 mm Hg at screening visit with or without ongoing glaucoma treatment. 10. Currently enrolled in an investigational drug or device study for chronic ocular GvHD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified SANDE Questionnaire - Frequency, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? |
| Corneal Fluorescein Stain - Central, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Fluorescein Stain - Total, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes. |
| Blurred Vision, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant. |
| Photophobia, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant. |
| Lid Edema, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain. |
| Lid Erythema, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain. |
| Lid Margin Ulceration, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain. |
| Conjunctival Hyperemia, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain. |
| Dryness, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant. |
| Ocular Pain, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant. |
| Airflow Sensitivity, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant. |
| Modified SANDE Questionnaire - Frequency, Change From Baseline | 6 weeks | Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? |
| Corneal Fluorescein Stain - Central, Change From Baseline | 6 weeks | Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes. |
| Modified SANDE Questionnaire - Global, Change From Baseline | 2 weeks | Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Corneal Fluorescein Stain - Total | 1 year | Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes. |
| Blurred Vision | 1 year | Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant. |
| Lid Edema | 1 year | Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining. |
| Lid Erythema | 1 year | Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining. |
| Lid Ulceration | 1 year | Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining. |
| Conjunctival Hyperemia | 1 year | Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining. |
| Modified SANDE Questionnaire - Frequency | 1 year | Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? |
| Modified SANDE Questionnaire - Global | 1 year | Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation? |
| Corneal Fluorescein Stain - Central | 1 year | Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes. |
Countries
United States
Participant flow
Recruitment details
Double masked phase 10 weeks. Both Pro-ocular and Placebo groups received active treatment after 10 weeks for remainder of 2 years total from first dose..
Participants by arm
| Arm | Count |
|---|---|
| Pro-ocular™ Pro-ocular™ 1% topical gel | 22 |
| Placebo Placebo topical gel | 11 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Long Term Period | Death | 1 | 1 |
| Long Term Period | Lost to Follow-up | 7 | 2 |
| Masked Period | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo | Pro-ocular™ |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 12.6 | 58.9 years STANDARD_DEVIATION 13.2 | 61.9 years STANDARD_DEVIATION 12.48 |
| Concomitant artificial tears and gel | 30 Participants | 9 Participants | 21 Participants |
| Concomitant ocular ciclosporin | 4 Participants | 2 Participants | 2 Participants |
| Concomitant ocular corticosteroid | 23 Participants | 8 Participants | 15 Participants |
| Concomitant systemic anti-inflammatory | 20 Participants | 9 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 11 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| NIH Eye Score Score 0-1 | 0 Participants | 0 Participants | 0 Participants |
| NIH Eye Score Score 2 | 18 Participants | 5 Participants | 13 Participants |
| NIH Eye Score Score 3 | 15 Participants | 6 Participants | 9 Participants |
| Ocular Graft versus Host Diagnosis | 33 Participants | 11 Participants | 22 Participants |
| Punctal plugs history | 29 Participants | 11 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 9 Participants | 21 Participants |
| Region of Enrollment United States | 33 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 12 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 21 Participants | 8 Participants | 13 Participants |
| Time of HSCT to oGvHD Diagnosis | 31.6 months STANDARD_DEVIATION 33.8 | 40.0 months STANDARD_DEVIATION 49.9 | 27.5 months STANDARD_DEVIATION 22.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 22 | 0 / 22 | 1 / 11 | 0 / 11 |
| other Total, other adverse events | 21 / 22 | 17 / 22 | 11 / 11 | 8 / 11 |
| serious Total, serious adverse events | 8 / 22 | 0 / 22 | 7 / 11 | 2 / 11 |
Outcome results
Primary
Corneal Fluorescein Stain - Central, Change From Baseline
Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Central, Change From Baseline | -0.90 score on a scale | Standard Error 0.213 |
| Placebo | Corneal Fluorescein Stain - Central, Change From Baseline | 0.20 score on a scale | Standard Error 0.304 |
p-value: 0.0039Mixed Models Analysis
Primary
Modified SANDE Questionnaire - Frequency, Change From Baseline
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Frequency, Change From Baseline | -22.00 score on a scale | Standard Error 4.246 |
| Placebo | Modified SANDE Questionnaire - Frequency, Change From Baseline | -4.59 score on a scale | Standard Error 6.009 |
p-value: 0.0197Mixed Models Analysis
Secondary
Airflow Sensitivity, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Airflow Sensitivity, Change From Baseline | -1.69 score on a scale | Standard Error 0.407 |
| Placebo | Airflow Sensitivity, Change From Baseline | -0.53 score on a scale | Standard Error 0.583 |
p-value: 0.1032Mixed Models Analysis
Secondary
Airflow Sensitivity, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Airflow Sensitivity, Change From Baseline | -1.93 score on a scale | Standard Error 0.401 |
| Placebo | Airflow Sensitivity, Change From Baseline | -0.68 score on a scale | Standard Error 0.567 |
p-value: 0.0098ANCOVA
Secondary
Airflow Sensitivity, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Airflow Sensitivity, Change From Baseline | -1.76 score on a scale | Standard Error 0.407 |
| Placebo | Airflow Sensitivity, Change From Baseline | -0.31 score on a scale | Standard Error 0.567 |
p-value: 0.0389Mixed Models Analysis
Secondary
Blurred Vision, Change From Baseline
Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Blurred Vision, Change From Baseline | -2.23 score on a scale | Standard Error 0.404 |
| Placebo | Blurred Vision, Change From Baseline | -0.31 score on a scale | Standard Error 0.568 |
p-value: 0.0067Mixed Models Analysis
Secondary
Blurred Vision, Change From Baseline
Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Blurred Vision, Change From Baseline | -2.09 score on a scale | Standard Error 0.404 |
| Placebo | Blurred Vision, Change From Baseline | 0.39 score on a scale | Standard Error 0.568 |
p-value: 0.0005Mixed Models Analysis
Secondary
Blurred Vision, Change From Baseline
Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Blurred Vision, Change From Baseline | -2.07 score on a scale | Standard Error 0.4 |
| Placebo | Blurred Vision, Change From Baseline | 0.40 score on a scale | Standard Error 0.568 |
p-value: 0.0005Mixed Models Analysis
Secondary
Conjunctival Hyperemia, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Conjunctival Hyperemia, Change From Baseline | -1.72 score on a scale | Standard Error 0.24 |
| Placebo | Conjunctival Hyperemia, Change From Baseline | -0.99 score on a scale | Standard Error 0.333 |
p-value: 0.083Mixed Models Analysis
Secondary
Conjunctival Hyperemia, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Conjunctival Hyperemia, Change From Baseline | -1.50 score on a scale | Standard Error 0.235 |
| Placebo | Conjunctival Hyperemia, Change From Baseline | -0.70 score on a scale | Standard Error 0.333 |
p-value: 0.0515Mixed Models Analysis
Secondary
Conjunctival Hyperemia, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Conjunctival Hyperemia, Change From Baseline | -1.75 score on a scale | Standard Error 0.24 |
| Placebo | Conjunctival Hyperemia, Change From Baseline | -0.92 score on a scale | Standard Error 0.333 |
p-value: 0.044Mixed Models Analysis
Secondary
Corneal Fluorescein Stain - Central, Change From Baseline
Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Central, Change From Baseline | -0.93 score on a scale | Standard Error 0.216 |
| Placebo | Corneal Fluorescein Stain - Central, Change From Baseline | -0.01 score on a scale | Standard Error 0.304 |
p-value: 0.0138Mixed Models Analysis
Secondary
Corneal Fluorescein Stain - Central, Change From Baseline
Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Central, Change From Baseline | -1.18 score on a scale | Standard Error 0.216 |
| Placebo | Corneal Fluorescein Stain - Central, Change From Baseline | 0.06 score on a scale | Standard Error 0.307 |
p-value: 0.0014Mixed Models Analysis
Secondary
Corneal Fluorescein Stain - Total, Change From Baseline
Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Total, Change From Baseline | -3.97 score on a scale | Standard Error 0.537 |
| Placebo | Corneal Fluorescein Stain - Total, Change From Baseline | -1.54 score on a scale | Standard Error 0.763 |
p-value: -3.97Mixed Models Analysis
Secondary
Corneal Fluorescein Stain - Total, Change From Baseline
Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Total, Change From Baseline | -2.53 score on a scale | Standard Error 0.527 |
| Placebo | Corneal Fluorescein Stain - Total, Change From Baseline | -0.23 score on a scale | Standard Error 0.753 |
p-value: 0.0143Mixed Models Analysis
Secondary
Corneal Fluorescein Stain - Total, Change From Baseline
Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Total, Change From Baseline | -3.28 score on a scale | Standard Error 0.537 |
| Placebo | Corneal Fluorescein Stain - Total, Change From Baseline | -1.35 score on a scale | Standard Error 0.753 |
p-value: 0.0398Mixed Models Analysis
Secondary
Dryness, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Dryness, Change From Baseline | -3.67 score on a scale | Standard Error 0.398 |
| Placebo | Dryness, Change From Baseline | -2.28 score on a scale | Standard Error 0.554 |
p-value: 0.0435Mixed Models Analysis
Secondary
Dryness, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Dryness, Change From Baseline | -2.48 score on a scale | Standard Error 0.391 |
| Placebo | Dryness, Change From Baseline | -2.23 score on a scale | Standard Error 0.554 |
p-value: 0.7147Mixed Models Analysis
Secondary
Dryness, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Dryness, Change From Baseline | -2.91 score on a scale | Standard Error 0.398 |
| Placebo | Dryness, Change From Baseline | -2.76 score on a scale | Standard Error 0.554 |
p-value: 0.8251Mixed Models Analysis
Secondary
Lid Edema, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Edema, Change From Baseline | -2.21 score on a scale | Standard Error 0.21 |
| Placebo | Lid Edema, Change From Baseline | -0.98 score on a scale | Standard Error 0.293 |
p-value: 0.001Mixed Models Analysis
Secondary
Lid Edema, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Edema, Change From Baseline | -1.73 score on a scale | Standard Error 0.206 |
| Placebo | Lid Edema, Change From Baseline | -0.80 score on a scale | Standard Error 0.293 |
p-value: 0.0105Mixed Models Analysis
Secondary
Lid Edema, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Edema, Change From Baseline | -1.72 score on a scale | Standard Error 0.21 |
| Placebo | Lid Edema, Change From Baseline | -0.83 score on a scale | Standard Error 0.293 |
p-value: 0.0155Mixed Models Analysis
Secondary
Lid Erythema, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Erythema, Change From Baseline | -1.53 score on a scale | Standard Error 0.229 |
| Placebo | Lid Erythema, Change From Baseline | -0.58 score on a scale | Standard Error 0.317 |
p-value: 0.0117Mixed Models Analysis
Secondary
Lid Erythema, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Erythema, Change From Baseline | -1.08 score on a scale | Standard Error 0.224 |
| Placebo | Lid Erythema, Change From Baseline | -0.13 score on a scale | Standard Error 0.317 |
p-value: 0.016Mixed Models Analysis
Secondary
Lid Erythema, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Erythema, Change From Baseline | -1.42 score on a scale | Standard Error 0.229 |
| Placebo | Lid Erythema, Change From Baseline | -1.27 score on a scale | Standard Error 0.354 |
p-value: 0.4649Mixed Models Analysis
Secondary
Lid Margin Ulceration, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Margin Ulceration, Change From Baseline | -1.57 score on a scale | Standard Error 0.245 |
| Placebo | Lid Margin Ulceration, Change From Baseline | -0.59 score on a scale | Standard Error 0.341 |
p-value: 0.0225Mixed Models Analysis
Secondary
Lid Margin Ulceration, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Margin Ulceration, Change From Baseline | -1.85 score on a scale | Standard Error 0.245 |
| Placebo | Lid Margin Ulceration, Change From Baseline | -1.27 score on a scale | Standard Error 0.354 |
p-value: 0.1822Mixed Models Analysis
Secondary
Lid Margin Ulceration, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Margin Ulceration, Change From Baseline | -1.14 score on a scale | Standard Error 0.24 |
| Placebo | Lid Margin Ulceration, Change From Baseline | -0.01 score on a scale | Standard Error 0.341 |
p-value: 0.0082Mixed Models Analysis
Secondary
Modified SANDE Questionnaire - Frequency, Change From Baseline
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Frequency, Change From Baseline | -31.75 score on a scale | Standard Error 4.313 |
| Placebo | Modified SANDE Questionnaire - Frequency, Change From Baseline | -1.95 score on a scale | Standard Error 6.009 |
p-value: <0.0001Mixed Models Analysis
Secondary
Modified SANDE Questionnaire - Frequency, Change From Baseline
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Frequency, Change From Baseline | -30.72 score on a scale | Standard Error 4.313 |
| Placebo | Modified SANDE Questionnaire - Frequency, Change From Baseline | -2.18 score on a scale | Standard Error 6.009 |
p-value: 0.0002ANCOVA
Secondary
Modified SANDE Questionnaire - Global, Change From Baseline
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Global, Change From Baseline | -16.02 score on a scale | Standard Error 4.063 |
| Placebo | Modified SANDE Questionnaire - Global, Change From Baseline | -3.78 score on a scale | Standard Error 5.753 |
p-value: 0.0849Mixed Models Analysis
Secondary
Modified SANDE Questionnaire - Global, Change From Baseline
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Global, Change From Baseline | -25.87 score on a scale | Standard Error 4.128 |
| Placebo | Modified SANDE Questionnaire - Global, Change From Baseline | -1.04 score on a scale | Standard Error 0.006 |
p-value: 0.0006Mixed Models Analysis
Secondary
Modified SANDE Questionnaire - Global, Change From Baseline
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Global, Change From Baseline | -26.35 score on a scale | Standard Error 4.128 |
| Placebo | Modified SANDE Questionnaire - Global, Change From Baseline | -5.64 score on a scale | Standard Error 5.753 |
p-value: 0.0041Mixed Models Analysis
Secondary
Ocular Pain, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Ocular Pain, Change From Baseline | -1.64 score on a scale | Standard Error 0.31 |
| Placebo | Ocular Pain, Change From Baseline | -0.29 score on a scale | Standard Error 0.439 |
p-value: 0.013Mixed Models Analysis
Secondary
Ocular Pain, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Ocular Pain, Change From Baseline | -1.53 score on a scale | Standard Error 0.316 |
| Placebo | Ocular Pain, Change From Baseline | -0.99 score on a scale | Standard Error 0.439 |
p-value: 0.3205Mixed Models Analysis
Secondary
Ocular Pain, Change From Baseline
Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Ocular Pain, Change From Baseline | -1.86 score on a scale | Standard Error 0.316 |
| Placebo | Ocular Pain, Change From Baseline | -1.06 score on a scale | Standard Error 0.499 |
p-value: 0.1401Mixed Models Analysis
Secondary
Photophobia, Change From Baseline
Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Photophobia, Change From Baseline | -1.68 score on a scale | Standard Error 0.437 |
| Placebo | Photophobia, Change From Baseline | 0.62 score on a scale | Standard Error 0.613 |
p-value: 0.0028Mixed Models Analysis
Secondary
Photophobia, Change From Baseline
Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.
Time frame: 10 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Photophobia, Change From Baseline | -1.82 score on a scale | Standard Error 0.437 |
| Placebo | Photophobia, Change From Baseline | 0.01 score on a scale | Standard Error 0.612 |
p-value: 0.0067Mixed Models Analysis
Secondary
Photophobia, Change From Baseline
Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Photophobia, Change From Baseline | -1.23 score on a scale | Standard Error 0.432 |
| Placebo | Photophobia, Change From Baseline | 0.18 score on a scale | Standard Error 0.695 |
p-value: 0.0636Mixed Models Analysis
Other Pre-specified
Blurred Vision
Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Blurred Vision | 7.59 units on a scale | Standard Deviation 2.61 |
| Placebo | Blurred Vision | 1.66 units on a scale | Standard Deviation 2.768 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Blurred Vision
Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Blurred Vision | 7.59 units on a scale | Standard Deviation 2.61 |
| Placebo | Blurred Vision | 2.20 units on a scale | Standard Deviation 2.582 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Conjunctival Hyperemia
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Conjunctival Hyperemia | 3.67 score on a scale | Standard Deviation 2.354 |
| Placebo | Conjunctival Hyperemia | 0.46 score on a scale | Standard Deviation 0.886 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Conjunctival Hyperemia
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Conjunctival Hyperemia | 3.67 score on a scale | Standard Deviation 2.354 |
| Placebo | Conjunctival Hyperemia | 0.80 score on a scale | Standard Deviation 1.238 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Corneal Fluorescein Stain - Central
Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Central | 3.57 units on a scale | Standard Deviation 2.779 |
| Placebo | Corneal Fluorescein Stain - Central | 1.12 units on a scale | Standard Deviation 1.522 |
p-value: 0.0002t-test, 2 sided
Other Pre-specified
Corneal Fluorescein Stain - Central
Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Central | 3.57 units on a scale | Standard Deviation 2.779 |
| Placebo | Corneal Fluorescein Stain - Central | 0.77 units on a scale | Standard Deviation 1.224 |
p-value: 0.0001t-test, 2 sided
Other Pre-specified
Corneal Fluorescein Stain - Total
Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Total | 11.52 units on a scale | Standard Deviation 7.137 |
| Placebo | Corneal Fluorescein Stain - Total | 3.65 units on a scale | Standard Deviation 3.289 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Corneal Fluorescein Stain - Total
Fluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Corneal Fluorescein Stain - Total | 11.52 units on a scale | Standard Deviation 7.137 |
| Placebo | Corneal Fluorescein Stain - Total | 2.81 units on a scale | Standard Deviation 3.699 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Lid Edema
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Edema | 3.74 score on a scale | Standard Deviation 2.785 |
| Placebo | Lid Edema | 0.71 score on a scale | Standard Deviation 1.085 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Lid Edema
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Edema | 3.74 score on a scale | Standard Deviation 2.785 |
| Placebo | Lid Edema | 0.72 score on a scale | Standard Deviation 0.995 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Lid Erythema
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Erythema | 3.92 score on a scale | Standard Deviation 2.738 |
| Placebo | Lid Erythema | 1.17 score on a scale | Standard Deviation 1.457 |
p-value: 0.0001t-test, 2 sided
Other Pre-specified
Lid Erythema
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Erythema | 3.92 score on a scale | Standard Deviation 2.738 |
| Placebo | Lid Erythema | 0.80 score on a scale | Standard Deviation 1.144 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Lid Ulceration
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Ulceration | 4.07 score on a scale | Standard Deviation 2.289 |
| Placebo | Lid Ulceration | 1.14 score on a scale | Standard Deviation 1.143 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Lid Ulceration
Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Lid Ulceration | 4.07 score on a scale | Standard Deviation 2.289 |
| Placebo | Lid Ulceration | 0.42 score on a scale | Standard Deviation 0.628 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Modified SANDE Questionnaire - Frequency
Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Time frame: 2 years
Population: The total number of participants were combined in one group for the 2 year analysis as all participants were dosed with active Pro-ocular after 10 weeks.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Frequency | 82.03 units on a scale | Standard Deviation 11.719 |
| Placebo | Modified SANDE Questionnaire - Frequency | 35.29 units on a scale | Standard Deviation 27.637 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Modified SANDE Questionnaire - Frequency
Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Time frame: 1 year
Population: The total number of participants were combined in one group for the 1 year analysis as all participants were dosed with active Pro-ocular after 10 weeks.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Frequency | 82.03 units on a scale | Standard Deviation 11.719 |
| Placebo | Modified SANDE Questionnaire - Frequency | 33.04 units on a scale | Standard Deviation 27.517 |
Comparison: Score in 1 year compared to baselinep-value: <0.00001t-test, 2 sided
Other Pre-specified
Modified SANDE Questionnaire - Global
Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?
Time frame: 2 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Global | 74.39 units on a scale | Standard Deviation 16.62 |
| Placebo | Modified SANDE Questionnaire - Global | 31.04 units on a scale | Standard Deviation 22.037 |
p-value: <0.00001t-test, 2 sided
Other Pre-specified
Modified SANDE Questionnaire - Global
Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pro-ocular™ | Modified SANDE Questionnaire - Global | 74.39 units on a scale | Standard Deviation 16.62 |
| Placebo | Modified SANDE Questionnaire - Global | 32.63 units on a scale | Standard Deviation 24.407 |
p-value: <0.00001t-test, 2 sided