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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational eye drop | Experimental | Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxymethylcellulose sodium, glycerin and polysorbate 80 | Device | 1 drop in each eye three times a day for a period of 30 (± 4) days |
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| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Evaporation Rate | The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10^-7 g/cm^2 /s and recorded for relative humidity of 25% to 35%. | after 30 days of eyedrop usage |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break Up Time | The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OTG Research & Consultancy | London | England | SW1E 6AU | United Kingdom |
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The subjects were selected from the existing clinical population of Optometric Technology Group Ltd (OTG Research & Consultancy). The subjects, fulfilling the criteria for inclusion were invited in a random fashion to participate in the study until the test population was achieved.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Eye Drop | Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| after 30 days of eyedrop usage |
| Ocular Surface Disease Index Score | The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient's ability to function. The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability. | after 30 days of eye drop usage |
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| NOT COMPLETED |
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The analysis was per protocol hence on 35 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Eye Drop | Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Tear Film Evaporation Rate | The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10^-7 g/cm^2 /s and recorded for relative humidity of 25% to 35%. | The analysis was carried out on subjects having completed the study according to the protocol e.g. 35 | Posted | Mean | Standard Deviation | 10^-7g/cm^2/sec | after 30 days of eyedrop usage |
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| Secondary | Tear Break Up Time | The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis. | The analysis was carried out on subjects having completed the study according to the protocol e.g. 35 | Posted | Mean | Standard Deviation | seconds | after 30 days of eyedrop usage |
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| Secondary | Ocular Surface Disease Index Score | The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient's ability to function. The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability. | Posted | Mean | Standard Deviation | points | after 30 days of eye drop usage |
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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 | Investigational Eye Drop | Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness | 0 | 36 | 3 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stye | Eye disorders |
| |||
| Allergic response | Skin and subcutaneous tissue disorders |
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| Bunion surgery | Surgical and medical procedures |
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Publication policy
The investigation data is wholly owned by the Sponsor. The results of the investigation may not be used in publications or presentations without the written permission of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michel Guillon | Optometric Technology Group | +44 2072224224 | mguillon@otg.co.uk |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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