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This study will access changes in tear protein levels and symptoms of dry eye following insertion of a punctal plug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Punctal plug | Experimental | Punctal plugs inserted into the study eye on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Punctal Plug | Device | Punctal plugs inserted into the study eye on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye | A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye. | Week 0 (Baseline) |
| Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye | A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye. | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Fluorescein Staining Score in the Study Eye | The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26774908 | Background | Tong L, Beuerman R, Simonyi S, Hollander DA, Stern ME. Effects of Punctal Occlusion on Clinical Signs and Symptoms and on Tear Cytokine Levels in Patients with Dry Eye. Ocul Surf. 2016 Apr;14(2):233-41. doi: 10.1016/j.jtos.2015.12.004. Epub 2016 Jan 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Punctal Plug | Punctal plugs inserted into the study eye on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants for analysis includes all patients who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Punctal Plug | Punctal plugs inserted into the study eye on Day 1. |
| 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 | Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye | A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye. | All patients who completed the study | Posted | Mean | Standard Deviation | picogram/milliliter/millimeter(pg/ml/mm) | Week 0 (Baseline) |
|
Adverse events (AEs) and serious adverse events (SAEs) were collected over the 3 week study period.
All patients enrolled in the study were used for the analysis of adverse events (AEs) and serious adverse events (SAEs).
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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 | Punctal Plug | Punctal plugs inserted into the study eye on Day 1. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000070635 | Punctal Plugs |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Week 0 (Baseline), Week 3 |
| Tear Film Break-up Time (TBUT) | TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film. | Week 0 (Baseline), Week 3 |
| Schirmer's Test Score | The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. | Week 0 (Baseline), Week 3 |
| Dry Eye Questionnaire Irritation Score | Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms. | Week 0 (Baseline), Week 3 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Corneal Fluorescein Staining Score in the Study Eye | The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition. | All patients who completed the study | Posted | Mean | Standard Deviation | Scores on a Scale | Week 0 (Baseline), Week 3 |
|
|
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| Secondary | Tear Film Break-up Time (TBUT) | TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film. | All patients who completed the study | Posted | Mean | Standard Deviation | Seconds | Week 0 (Baseline), Week 3 |
|
|
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| Secondary | Schirmer's Test Score | The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. | All patients who completed the study | Posted | Mean | Standard Deviation | Millimeters (mm) | Week 0 (Baseline), Week 3 |
|
|
|
| Secondary | Dry Eye Questionnaire Irritation Score | Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms. | All patients who completed the study | Posted | Mean | Standard Deviation | Millimeters (mm) | Week 0 (Baseline), Week 3 |
|
|
|
| Primary | Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye | A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye. | All patients who completed the study | Posted | Mean | Standard Deviation | picogram/milliliter/millimeter(pg/ml/mm) | Week 3 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Measurements |
|---|---|
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| Week 0 (Baseline): Temporal |
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| Week 0 (Baseline): Central |
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| Week 3: Superior |
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| Week 3: Inferior |
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| Week 3: Nasal |
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| Week 3: Temporal |
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| Week 3: Central |
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| Title | Measurements |
|---|---|
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| IL13 |
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| IL17A |
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| IL1B |
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| MMP9 |
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| IL2 |
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| IL4 |
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| IL6 |
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| IP10 |
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| MCP1 |
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| MIP1A |
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| RANTE |
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| TNFA |
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