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To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | carboxymethylcellulose 0.5%, glycerin 0.9% |
|
| 2 | Active Comparator | sodium hyaluronate 0.18% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboxymethylcellulose 0.5% +glycerin 0.9% | Drug | To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement. | Baseline, Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. | Baseline, Week 2 |
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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 |
|---|---|---|---|---|---|---|
| Ulm | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | carboxymethylcellulose 0.5%, glycerin 0.9% |
| FG001 | Sodium Hyaluronate 0.18% | sodium hyaluronate 0.18% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | carboxymethylcellulose 0.5%, glycerin 0.9% |
| BG001 | Sodium Hyaluronate 0.18% | sodium hyaluronate 0.18% |
| 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 | Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement. | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 2 |
|
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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 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | carboxymethylcellulose 0.5%, glycerin 0.9% |
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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 |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
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|
| sodium hyaluronate 0.18% | Drug | To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container. |
|
|
| Change From Baseline in Corneal Staining at Week 2 |
Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. |
| Baseline, Week 2 |
| Change From Baseline in Conjunctival Staining (Temporal) at Week 2 | Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Baseline, Week 2 |
| Change From Baseline in Conjunctival Staining (Nasal) at Week 2 | Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Baseline, Week 2 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sodium Hyaluronate 0.18% |
sodium hyaluronate 0.18% |
|
|
| Secondary | Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Seconds | Baseline, Week 2 |
|
|
|
| Secondary | Change From Baseline in Corneal Staining at Week 2 | Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 2 |
|
|
|
| Secondary | Change From Baseline in Conjunctival Staining (Temporal) at Week 2 | Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 2 |
|
|
|
| Secondary | Change From Baseline in Conjunctival Staining (Nasal) at Week 2 | Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 2 |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Sodium Hyaluronate 0.18% | sodium hyaluronate 0.18% | 0 | 37 | 0 | 37 |
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.
| D002241 |
| Carbohydrates |