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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro-ocular™ | Experimental | Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime. |
|
| Placebo | Placebo Comparator | Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pro-ocular™ topical gel | Drug | Topical gel for forehead dermal application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | 2 weeks |
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | 6 weeks |
| Modified SANDE Questionnaire - Frequency, Change From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | 1 year |
| Modified SANDE Questionnaire - Frequency |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhonghui K Luo, MD, PhD | Massachusetts Eye and Ear, Longwood | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Longwood | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33942724 | Result | Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther. 2021 May;27(5):433.e1-433.e8. doi: 10.1016/j.jtct.2021.02.008. Epub 2021 Feb 14. |
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Data may be shared with other investigators.
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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..
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| ID | Title | Description |
|---|---|---|
| FG000 | Pro-ocular™ | Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime. Pro-ocular™ group received active for 2 years beginning with first dose. The first 10 weeks were masks, whereas the remaining time was open-label active. |
| FG001 | Placebo | Topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime. Placebo group was dosed with placebo topical gel for the first 10 weeks, followed by open-label active for the remainder of 2 years from first dosing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Masked Period |
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| ||||||||||||||||||
| Long Term Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pro-ocular™ | Pro-ocular™ 1% topical gel |
| BG001 | Placebo | Placebo topical gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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? | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pro-ocular™ for 2 Years | Pro-ocular™ 1% topical gel applied to forehead twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment | Headaches were light and brief, lasting 10 min to 2 hours, occurring within the first 2 weeks of the study only. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wei-wei Chang, PhD; President | Glia, LLC | (617) 794-8922 | chang@gliacell.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2020 | Oct 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2019 | Oct 14, 2024 | SAP_001.pdf |
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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.
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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.
| Placebo topical gel |
| Drug |
Topical gel for forehead dermal application |
|
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? |
| 10 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 2 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
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? |
| 2 years |
| 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? | 1 year |
| 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? | 2 years |
| Corneal Fluorescein Stain - Central | Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes. | 1 year |
| Corneal Fluorescein Stain - Central | Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes. | 2 years |
| 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. | 1 year |
| 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. | 2 years |
| 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. | 1 year |
| 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. | 2 years |
| 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. | 1 year |
| 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. | 2 years |
| 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. | 1 year |
| 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. | 2 years |
| 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. | 1 year |
| 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. | 2 years |
| 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. | 1 year |
| 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. | 2 years |
| NOT COMPLETED |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ocular Graft versus Host Diagnosis | Count of Participants | Participants |
|
| Time of HSCT to oGvHD Diagnosis | Mean | Standard Deviation | months |
|
| NIH Eye Score | The NIH Eye Score is a scoring system used to measure the severity of dry eyes in patients with chronic ocular graft-versus-host disease (GVHD). The score ranges from 0-3, with 0 indicating no dry eye, 1 indicating mild dry eye, 2 indicating moderate dry eye, and 3 indicating severe dry eye. | Count of Participants | Participants |
|
| Concomitant artificial tears and gel | Concomitant artificial tears and gel use | Count of Participants | Participants |
|
| Concomitant ocular corticosteroid | Concomitant ocular corticosteroid use. | Count of Participants | Participants |
|
| Concomitant ocular ciclosporin | Concomitant ciclosporin eye drops use. | Count of Participants | Participants |
|
| Punctal plugs history | Ever had punctal plugs inserted | Count of Participants | Participants |
|
| Concomitant systemic anti-inflammatory | Concomitant use of systemic anti-inflammatory medications | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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? | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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? | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 10 weeks |
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| 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? | 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 year |
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| 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? | 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 2 years |
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| 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? | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 year |
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| 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? | Posted | Least Squares Mean | Standard Deviation | units on a scale | 2 years |
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| 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 2 years |
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| 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 2 years |
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| 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 2 years |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 2 years |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 2 years |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 2 years |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 2 years |
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| 1 |
| 22 |
| 8 |
| 22 |
| 21 |
| 22 |
| EG001 | Pro-ocular™ for 10-week Masked Period Only | Pro-ocular™ 1% topical gel applied to forehead twice daily for 10-week masked period only | 0 | 22 | 0 | 22 | 17 | 22 |
| EG002 | Placebo+Active for 2 Years Total | Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period, followed by active gel for the remaining 2 year period | 1 | 11 | 7 | 11 | 11 | 11 |
| EG003 | Placebo for 10-week Masked Period Ony | Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period only | 0 | 11 | 2 | 11 | 8 | 11 |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
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| Acute lymphocytic leukaemia recurrent | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Endocrine neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
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| Vascular operation | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
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| Small bowel obstruction | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Hip surgery | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dyspnea | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Rib fracture | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Corneal perforation | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Corneal thinning | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Corneal epithelium defect | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Mycardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Cerebrovascular accident | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Neurosensory hypoacusis | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
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| Ophthalmic herpes simplex | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Corneal infiltrates | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Parathyroidectomy | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment | Rhinorrhea or runny nose in almost all cases were brief, and occurred within the first 2 weeks of the study only. |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Corneal abrasion | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Discomfort | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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