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Study terminated due to corporate decision.
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This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Treatment | Other | No Treatment was given in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) | The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens | The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) | The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye. | Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure. | Posted | Mean | Standard Deviation | µm | Day 1 | Eyes | Participants |
|
|
Adverse Events were collected from Screening through Day 1 (Up to 5 Weeks)
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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 | All Participants | Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported. | Day 1 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| Eyes |
|
|
| Secondary | Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens | The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported. | Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure. | Posted | Number | eye | Day 1 | Eyes | Participants |
|
|
|
| Secondary | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported. | Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure. | Posted | Number | eye | Day 1 | Eyes | Participants |
|
|
|
| 0 |
| 206 |
| 0 |
| 206 |
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 90 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 |
|---|---|
|
| Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Step Grade 2.5 |
|
| Step Grade 3.0 |
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| Step Grade 3.5 |
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| Step Grade 4.0 |
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| Step Grade 4.5 |
|
| Step Grade 5.0 |
|
| Step Grade 5.5 |
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| Step Grade 6.0 |
|
| Step Grade 6.5 |
|
| Step Grade 7.0 |
|
| Step Grade 7.5 |
|