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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).
Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.
A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month double-masked treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXR-159 Ophthalmic Solution 3 mg/mL | Experimental | AXR-159 Low Dose |
|
| AXR-159 Ophthalmic Solution 30 mg/mL | Experimental | AXR-159 Mid Dose |
|
| AXR-159 Ophthalmic Solution 50 mg/mL | Experimental | AXR-159 High Dose |
|
| AXR-159 Ophthalmic Solution Vehicle | Placebo Comparator | Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXR-159 | Drug | AXR-159 Ophthalmic Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inferior Corneal Staining Score | Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome. | Month 3 |
| Eye Dryness | Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Ocular Surface and Disease Index (OSDI) © for Dry Eye | Change from baseline in OSDI © score on a subject level. The 12-question OSDI © is assessed on a total scale from 0 to 100, where higher scores represent greater disability. A greater negative change from baseline indicates a better outcome. | Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail L Torkildson, MD | Andover Eye Associates, 138 Haverhill Street, Andover MA 01810 | Principal Investigator |
| Kenneth R Kenyon, MD | Andover Eye Associates, 675 Paramount Drive, Raynham, MA 02767 | Principal Investigator |
| Eugene McLaurin, MD | Total Eye Care, P.A., 6060 Primacy Parkway, Memphis, TN 38119 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States | ||
| Andover Eye Associates |
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All subjects who met the enrollment criteria at the initial screening visit were assigned to a 2-week run-in period on thrice daily topical vehicle. At the conclusion of the run-in period, 102 subjects again met the enrollment criteria and were randomized to either active or vehicle groups.
Participants were recruited based on prespecified inclusion and exclusion criteria between June 2018 and September 2018. Of 265 subjects initially screened, 102 subjects were randomized. The first subject's screening visit was on June 26; the last subject's exit visit was on December 28.
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| ID | Title | Description |
|---|---|---|
| FG000 | AXR-159 Ophthalmic Solution 50 mg/mL | AXR-159 High Dose AXR-159: AXR-159 Ophthalmic Solution |
| FG001 | AXR-159 Ophthalmic Solution Vehicle | Control Group AXR-159: AXR-159 Ophthalmic Solution Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | AXR-159 Ophthalmic Solution 50 mg/mL | AXR-159 High Dose AXR-159: AXR-159 Ophthalmic Solution |
| BG001 | AXR-159 Ophthalmic Solution Vehicle | Control Group AXR-159: AXR-159 Ophthalmic Solution Vehicle |
| 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 | Inferior Corneal Staining Score | Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome. | Modified Intent-to-Treat population with last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
For each subject, AEs were reported over a 12-week study period, starting from the randomization visit and start of treatment until the exit visit. Any serious adverse event (SAE) occurring during the study period and for 12 weeks after the last dose of study drug were to be immediately reported.
All AEs spontaneously reported by the subject and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures. Documentation as to the nature, date of onset, end date, severity, and relationship to Investigational Product, action(s) taken, seriousness, and outcome of any sign or symptom observed by the physician or reported by the subject upon indirect questioning.
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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 | AXR-159 Ophthalmic Solution 50 mg/mL | AXR-159 High Dose AXR-159: AXR-159 Ophthalmic Solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment | Urethral Bleeding secondary to recent Cystoscope procedure; considered unrelated to study drug (vehicle) and resolved during study period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
The study was planned as a 2-stage study but has been terminated after completion of Stage 1 due to lack of funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Achim Krauss | AxeroVision, Inc. | +1 (484) 238-6255 | achim.h.krauss@gmail.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 | Feb 17, 2018 | Dec 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2019 | Dec 8, 2022 | 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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| Vehicle | Drug | AXR-159 Ophthalmic Solution Vehicle |
|
| Schirmer's Test |
Change from baseline in Schirmer's Test score in the study eye. Unanesthetized Schirmer's Test measures the length of the moistened area of a test strip, placed in the lower temporal lid margin of each eye, in mm following a 5-minute exposure period. Greater positive numbers indicate a better outcome. |
| Month 3 |
| Tear Film Break-up Time (TBUT) | Change from baseline in the study eye with a greater positive increase indicating a better outcome. Following the instillation of a sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye and several blinks over 30 seconds, the examiner monitored the integrity of the tear film with the aid of a slit lamp, noting the time it takes to form micelles from the time that the eye is opened. TBUT was measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. Values reported are for the study eye. | Month 3 |
| Conjunctival Redness Score | Change from baseline of Ora Calibra® Conjunctival Redness Scale for Dry Eye. Scores range from 0 to 4 with 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; with higher numbers indicating more conjunctival redness. Greater negative numbers indicate a better outcome. Values reported are for the study eye. | Month 3 |
| Total Lissamine Green Conjunctival Staining | Change from baseline of Oxford Grading Scale measuring staining within a range from 0-5 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe, 5=Confluent) for each panel (temporal and nasal) and 0-10 as the sum of both panel scores for the total exposed inter-palpebral conjunctiva. Larger negative numbers indicate reduced staining and a better outcome. Values reported are for the study eye. | Month 3 |
| Raynham |
| Massachusetts |
| 02767 |
| United States |
| Total Eye Care, P.A. | Memphis | Tennessee | 38119 | United States |
| 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 |
|
| Inferior Corneal Staining Score | Score in the study eye based on Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe). Higher numbers indicate more staining and a worse outcome. | Baseline Measure population = Modified Intent-to-Treat population with LOCF; Overall population = Safety population | Mean | Full Range | units on a scale |
|
| Eye Dryness | Using the visual analogue scale (VAS) subjects rated eye dryness on a subject level across both eyes by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. | Baseline Measure population = Modified Intent-to-Treat population with LOCF; Overall population = Safety population | Mean | Full Range | units on a scale |
|
| Total Ocular Surface and Disease Index (OSDI) © for Dry Eye | The 12-question OSDI © is assessed on a subject level on a total scale from 0 to 100, where higher scores represent greater disability. | Baseline Measure population = Modified Intent-to-Treat population with observed data only; Overall population = Safety population | Mean | Full Range | units on a scale |
|
| Schirmer's Test | Unanesthetized Schirmer's Test measures the length of the moistened area of a test strip, placed in the lower temporal lid margin in the study eye, in mm following a 5-minute exposure period. Values of <10 mm are considered to represent a low tear volume. | Baseline Measure population = Modified Intent-to-Treat population with observed data only; Overall population = Safety population | Mean | Full Range | millimeters |
|
| Tear Film Break-up Time (TBUT) | Following the instillation of a sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye and several blinks over 30 seconds, the examiner monitored the integrity of the tear film with the aid of a slit lamp, noting the time it takes to form micelles from the time that the eye is opened. TBUT was measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. Values reported are for the study eye. | Baseline Measure population = Modified Intent-to-Treat population with observed data only; Overall population = Safety population | Mean | Full Range | seconds |
|
| Conjunctival Redness Score | Assessed with the Ora Calibra® Conjunctival Redness Scale for Dry Eye. Scores range from 0 to 4 with 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; with higher numbers indicating more conjunctival redness. Values reported are for the study eye. | Baseline Measure population = Modified Intent-to-Treat population with observed data only; Overall population = Safety population | Mean | Full Range | units on a scale |
|
| Total Lissamine Green Conjunctival Staining | Change from baseline of Oxford Grading Scale measuring staining within a range from 0-5 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe, 5=Confluent) for each panel (temporal and nasal) and 0-10 as the sum of both panel scores for the total exposed inter-palpebral conjunctiva. Higher numbers indicate more staining and a worse condition. Values reported are for the study eye. | Baseline Measure population = Modified Intent-to-Treat population with observed data only; Overall population = Safety population | Mean | Full Range | units on a scale |
|
|
|
| Primary | Eye Dryness | Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome. | Modified Intent-to-Treat population with last observation carried forward | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
|
|
| Secondary | Total Ocular Surface and Disease Index (OSDI) © for Dry Eye | Change from baseline in OSDI © score on a subject level. The 12-question OSDI © is assessed on a total scale from 0 to 100, where higher scores represent greater disability. A greater negative change from baseline indicates a better outcome. | Modified Intent-to-Treat with observed data only | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
|
|
| Secondary | Schirmer's Test | Change from baseline in Schirmer's Test score in the study eye. Unanesthetized Schirmer's Test measures the length of the moistened area of a test strip, placed in the lower temporal lid margin of each eye, in mm following a 5-minute exposure period. Greater positive numbers indicate a better outcome. | Modified Intent-to-Treat population with observed data only | Posted | Mean | Standard Deviation | millimeters | Month 3 |
|
|
|
| Secondary | Tear Film Break-up Time (TBUT) | Change from baseline in the study eye with a greater positive increase indicating a better outcome. Following the instillation of a sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye and several blinks over 30 seconds, the examiner monitored the integrity of the tear film with the aid of a slit lamp, noting the time it takes to form micelles from the time that the eye is opened. TBUT was measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. Values reported are for the study eye. | Modified Intent-to-Treat with observed data only | Posted | Mean | Standard Deviation | seconds | Month 3 |
|
|
|
| Secondary | Conjunctival Redness Score | Change from baseline of Ora Calibra® Conjunctival Redness Scale for Dry Eye. Scores range from 0 to 4 with 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; with higher numbers indicating more conjunctival redness. Greater negative numbers indicate a better outcome. Values reported are for the study eye. | Modified Intent-to-Treat population with observed data only | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
|
|
| Secondary | Total Lissamine Green Conjunctival Staining | Change from baseline of Oxford Grading Scale measuring staining within a range from 0-5 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe, 5=Confluent) for each panel (temporal and nasal) and 0-10 as the sum of both panel scores for the total exposed inter-palpebral conjunctiva. Larger negative numbers indicate reduced staining and a better outcome. Values reported are for the study eye. | Modified Intent-to-Treat population with observed data only | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 34 |
| 54 |
| EG001 | AXR-159 Ophthalmic Solution Vehicle | Control Group AXR-159: AXR-159 Ophthalmic Solution Vehicle | 0 | 48 | 1 | 48 | 7 | 48 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Instillation site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Instillation site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|