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| Name | Class |
|---|---|
| Topivert Pharma Ltd | INDUSTRY |
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In subjects with Dry Eye Syndrome:
The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.
The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.
This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.
Eligible subjects will be randomized double masked to either TOP1630 or placebo.
Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.
Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | TOP1630 Ophthalmic Solution |
|
| Placebo | Placebo Comparator | Placebo (Vehicle) Ophthalmic Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOP1630 Ophthalmic Solution | Drug | Bilateral ocular drug administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual Acuity will be measured using the EDTRS chart to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame |
| Slit-lamp Biomicroscopy | Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities | Part 1: 12 days time frame; Part 2: 35 days time frame |
| Drop Comfort Assessment | The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable | Part 1: 12 days time frame |
| Intraocular Pressure | a non-contact tonometer will be used to perform IOP to assess changes from baseline. | Part 1: 12 days time frame; Part 2: 35 days time frame |
| Corneal Sensitivity | The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6 | Part 1: 12 days time frame; Part 2: 35 days time frame |
| Undilated Fundoscopy | Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities | Part 2: 35 days time frame |
| Vital Signs - Pulse |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Discomfort | Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant) | Part 2: 35 days time frame |
| Dry Eye Symptoms | Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst) |
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Inclusion Criteria:
Additionally for Part 2
Symptoms of dry eye syndrome including:
Signs of dry eye syndrome including:
Conjunctival staining score
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | TOP1630 Ophthalmic Solution TOP1630 Ophthalmic Solution: Bilateral ocular drug administration |
| FG001 | Placebo | Placebo (Vehicle) Ophthalmic Solution Placebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | TOP1630 Ophthalmic Solution TOP1630 Ophthalmic Solution: Bilateral ocular drug administration |
| BG001 | Placebo | Placebo (Vehicle) Ophthalmic Solution Placebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Visual Acuity | Visual Acuity will be measured using the EDTRS chart to assess changes from baseline | Number analyzed represents the sum of numbers analyzed Part 1 and Part 2 | Posted | Mean | Standard Deviation | logMAR | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
4 months
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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 | Active | TOP1630 Ophthalmic Solution TOP1630 Ophthalmic Solution: Bilateral ocular drug administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Topivert Pharma Ltd | +44 203 763 9469 | info@topivert.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 | Jan 20, 2017 | Sep 9, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2017 | Jan 21, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo to TOP1630 Ophthalmic Solution |
| Drug |
Bilateral ocular drug administration |
|
Changes in vital signs is performed to assess changes from baseline
| Part 1: 12 days time frame; Part 2: 35 days time frame |
| Vital Signs - O2 Saturation | Changes in vital signs is performed to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame |
| Vital Signs - Systolic Blood Pressure | Changes in vital signs is performed to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame |
| Vital Signs - Diastolic Blood Pressure | Changes in vital signs is performed to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame |
| Part 2: 35 days time frame |
| Dry Eye Signs | Dry eye syndrome staining Score assessments (total lissamine green staining score, 0-20 where 0 = no staining) | Part 2: 35 days time frame |
| Tear Film Break up Time | Tear film break up time measured (in seconds) after instillation of sodium fluorescein solution | Part 2: 35 days time frame |
| Schirmer's Test | Measurement of Schirmer test strips (mm length of moistened area after 5 minutes) | Part 2: 35 days time frame |
| Daily Symptom Assessment | Daily symptom assessment using diary cards - outcome for worst symptom, ie symptom with highest severity score at baseline for each patient; calculated using the daily average between visit 3b to visit 4b Ora Calibra Ocular Discomfort & 4-Symptom Questionnaire (0-5 scale where 0 = none and 5 = worst) | Assessed daily between visit 3b (day 27) to visit 4b (day 35) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Slit-lamp Biomicroscopy | Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities | Posted | Number | participants | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
|
|
| Primary | Drop Comfort Assessment | The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable | Posted | Mean | Standard Deviation | score on a scale | Part 1: 12 days time frame |
|
|
|
| Primary | Intraocular Pressure | a non-contact tonometer will be used to perform IOP to assess changes from baseline. | Number analyzed comes from Part 1 and Part 2 | Posted | Mean | Standard Deviation | unit of measure "mmHg" | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
|
|
| Primary | Corneal Sensitivity | The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6 | Number analyzed comes from Part 2 | Posted | Mean | Standard Deviation | unit of measure "mm" | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
|
|
| Primary | Undilated Fundoscopy | Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities | Posted | Count of Participants | Participants | Part 2: 35 days time frame |
|
|
|
| Primary | Vital Signs - Pulse | Changes in vital signs is performed to assess changes from baseline | Number analyzed comes from Part 1 and Part 2 | Posted | Mean | Standard Deviation | beats per minute | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
|
|
| Primary | Vital Signs - O2 Saturation | Changes in vital signs is performed to assess changes from baseline | Number analyzed comes from Part 1 and Part 2 | Posted | Mean | Standard Deviation | percentage of 02 saturation | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
|
|
| Primary | Vital Signs - Systolic Blood Pressure | Changes in vital signs is performed to assess changes from baseline | Number analyzed comes from Part 1 and Part 2 | Posted | Mean | Standard Deviation | mmHg | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
|
|
| Primary | Vital Signs - Diastolic Blood Pressure | Changes in vital signs is performed to assess changes from baseline | Number analyzed comes from Part 1 and Part 2 | Posted | Mean | Standard Deviation | mmHg | Part 1: 12 days time frame; Part 2: 35 days time frame |
|
|
|
| Secondary | Ocular Discomfort | Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant) | Posted | Mean | Standard Deviation | score on a scale | Part 2: 35 days time frame |
|
|
|
|
| Secondary | Dry Eye Symptoms | Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst) | Posted | Mean | Standard Deviation | score on a scale | Part 2: 35 days time frame |
|
|
|
|
| Secondary | Dry Eye Signs | Dry eye syndrome staining Score assessments (total lissamine green staining score, 0-20 where 0 = no staining) | Posted | Mean | Standard Deviation | score on a scale | Part 2: 35 days time frame |
|
|
|
|
| Secondary | Tear Film Break up Time | Tear film break up time measured (in seconds) after instillation of sodium fluorescein solution | Posted | Mean | Standard Deviation | Seconds | Part 2: 35 days time frame |
|
|
|
|
| Secondary | Schirmer's Test | Measurement of Schirmer test strips (mm length of moistened area after 5 minutes) | Posted | Mean | Standard Deviation | mm in 5 minutes | Part 2: 35 days time frame |
|
|
|
|
| Secondary | Daily Symptom Assessment | Daily symptom assessment using diary cards - outcome for worst symptom, ie symptom with highest severity score at baseline for each patient; calculated using the daily average between visit 3b to visit 4b Ora Calibra Ocular Discomfort & 4-Symptom Questionnaire (0-5 scale where 0 = none and 5 = worst) | Posted | Mean | Standard Deviation | score on a scale | Assessed daily between visit 3b (day 27) to visit 4b (day 35) |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 6 |
| 37 |
| EG001 | Placebo | Placebo (Vehicle) Ophthalmic Solution Placebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration | 0 | 32 | 0 | 32 | 4 | 32 |
| Eye Discharge | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Ocular itching | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Instillation site pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Instillation site discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Common cold | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
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| Part 2 |
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| Part 2 |
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| Part 2 |
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| Part 2 |
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| Part 2 |
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