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This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycerin and Polysorbate 80 based artificial tear | Active Comparator | Glycerin and Polysorbate 80 based artificial tear |
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| Artificial Tears Formulation 1 | Experimental | Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear |
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| Artificial Tears Formulation 2 | Experimental | Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerin and Polysorbate 80 based artificial tear | Drug | 1-2 drops in each eye, as needed, but at least twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90 | Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness. | Baseline (Day 1), Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90 | Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. |
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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 |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25659956 | Derived | Simmons PA, Carlisle-Wilcox C, Chen R, Liu H, Vehige JG. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015 Apr 1;37(4):858-68. doi: 10.1016/j.clinthera.2015.01.001. Epub 2015 Feb 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Artificial Tears Formulation 1 | Artificial Tears Formulation 1 |
| FG001 | Artificial Tears Formulation 2 | Artificial Tears Formulation 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear | Drug | 1-2 drops in each eye, as needed, but at least twice daily |
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| Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear | Drug | 1-2 drops in each eye, as needed, but at least twice daily |
|
| Baseline (Day 1), Day 90 |
| Change From Baseline in Tear Break-up Time (TBUT) at Day 90 | Change from baseline in TBUT at day 90. TBUT is 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 short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). | Baseline (Day 1), Day 90 |
| Change From Baseline in Corneal Staining at Day 90 | Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement). | Baseline (Day 1), Day 90 |
| Change From Baseline in Conjunctival Staining Severity Score at Day 90 | Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement). | Baseline (Day 1), Day 90 |
| FG002 | Glycerin and Polysorbate 80 Based Artificial Tear | Glycerin and Polysorbate 80 based artificial tear |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Artificial Tears Formulation 1 | Artificial Tears Formulation 1 |
| BG001 | Artificial Tears Formulation 2 | Artificial Tears Formulation 2 |
| BG002 | Glycerin and Polysorbate 80 Based Artificial Tear | Glycerin and Polysorbate 80 based artificial tear |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | 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 | Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90 | Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness. | Intent-to-treat, which includes all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline (Day 1), Day 90 |
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| Secondary | Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90 | Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. | Intent-to-treat, which includes all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline (Day 1), Day 90 |
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| Secondary | Change From Baseline in Tear Break-up Time (TBUT) at Day 90 | Change from baseline in TBUT at day 90. TBUT is 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 short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). | Intent-to-treat, which includes all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Seconds | Baseline (Day 1), Day 90 |
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| Secondary | Change From Baseline in Corneal Staining at Day 90 | Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement). | Intent-to-treat, which includes all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Day 90 |
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| Secondary | Change From Baseline in Conjunctival Staining Severity Score at Day 90 | Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement). | Intent-to-treat, which includes all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Day 90 |
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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 | Artificial Tears Formulation 1 | Artificial Tears Formulation 1 | 2 | 97 | 28 | 97 | ||
| EG001 | Artificial Tears Formulation 2 | Artificial Tears Formulation 2 | 0 | 95 | 14 | 95 | ||
| EG002 | Glycerin and Polysorbate 80 Based Artificial Tear | Glycerin and Polysorbate 80 based artificial tear | 4 | 96 | 37 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion induced | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
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| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Instillation site pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005990 | Glycerol |
| D011136 | Polysorbates |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| between 30 and 40 years |
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| >40 years |
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| Male |
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