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This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Planned Cataract Removal | Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. | Up to 60 Days Prior to Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9 | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of "Yes" to the Investigator Dry Eye History question. | Up to 60 days prior to cataract surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with planned cataract removal surgery
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandon | Manitoba | Canada | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Planned Cataract Removal | Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Planned Cataract Removal | Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered. |
| 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 | Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. | Per-protocol population included all enrolled participants who completed all the study assessments without major protocol violations. | Posted | Number | percentage of participants | Up to 60 Days Prior to Surgery |
|
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Adverse Events that did not resolve by the end of Baseline Visit 1 were followed for up to 30 days.
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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 | Patients With Planned Cataract Removal | Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered. |
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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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| Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention |
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis. |
| Up to 60 days prior to cataract surgery |
| Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome. | Up to 60 days prior to cataract surgery |
| Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds. | Up to 60 days prior to cataract surgery |
| Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. | Up to 60 days prior to cataract surgery |
| Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. | Up to 60 days prior to cataract surgery |
| Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator. | Up to 60 Days Prior to Surgery |
| Percentage of Participants With Elevated MMP-9 With Punctal Plugs | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator. | Up to 60 Days Prior to Surgery |
| Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome. | Up to 60 Days Prior to Surgery |
| Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32 | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). | Up to 60 Days Prior to Surgery |
| Halifax |
| Nova Scotia |
| Canada |
| Barrie | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Boisbriand | Quebec | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9 | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of "Yes" to the Investigator Dry Eye History question. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated data MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 days prior to cataract surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 days prior to cataract surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 days prior to cataract surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 days prior to cataract surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 days prior to cataract surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 days prior to cataract surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 Days Prior to Surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 With Punctal Plugs | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 Days Prior to Surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome. | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 Days Prior to Surgery |
|
|
|
| Secondary | Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32 | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). | Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis. | Posted | Number | percentage of participants | Up to 60 Days Prior to Surgery |
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| 0 |
| 204 |
| 0 |
| 204 |
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 less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
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