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The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Tear Formulation 1 | Experimental | Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear |
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| Artificial Tear Formulation 2 | Experimental | Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear |
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| Glycerin and Polysorbate 80 based artificial tear | Active Comparator | Glycerin and Polysorbate 80 based artificial tear |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear | Drug | 1 to 2 drops into each eye three times per day |
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| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Questionnaire Mean Scores at 1 Week | Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst. | 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening. |
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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 |
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 products in a randomly assigned order. The subject used 1 product at a time for a duration of 1 week before switching to the next assigned product (e.g., with treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence ABC | Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear |
| FG001 | Sequence ACB |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment 1 |
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| Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear | Drug | 1 to 2 drops into each eye three times per day |
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| Glycerin and Polysorbate 80 based artificial tear | Drug | 1 to 2 drops into each eye three times per day |
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| 1 Week |
| Best-Corrected Visual Acuity (BCVA) Status at 1 Week | BCVA status at 1 week reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more in at least 1 eye; "No Change" equals change between -2 to +2 lines in either eye; "Worse" equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. | 1 Week |
| The Number of Ophthalmic Adverse Events at 1 Week | The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product | 1 Week |
Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
| FG002 | Sequence BAC | Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear |
| FG003 | Sequence BCA | Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 |
| FG004 | Sequence CAB | Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 |
| FG005 | Sequence CBA | Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 |
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| NOT COMPLETED |
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| Treatment 2 |
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| Treatment 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Study Participants |
| 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 | Tolerability Questionnaire Mean Scores at 1 Week | Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst. | Safety population, which consisted of all patients who started the study (randomized) and received treatment. | Posted | Mean | Standard Deviation | Scores on a scale | 1 Week |
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| Secondary | Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening. | Safety population, which consisted of all patients who started the study (randomized) and received treatment. | Posted | Number | Number of Patients | 1 Week |
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| Secondary | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | BCVA status at 1 week reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more in at least 1 eye; "No Change" equals change between -2 to +2 lines in either eye; "Worse" equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. | Safety population, which consisted of all patients who started the study (randomized) and received treatment. | Posted | Number | Number of Patients | 1 Week |
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| Secondary | The Number of Ophthalmic Adverse Events at 1 Week | The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product | Safety population, which consisted of all patients who started the study (randomized) and received treatment. | Posted | Number | Number of adverse events | 1 Week |
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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 Tear Formulation 1 | Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear | 0 | 47 | 0 | 47 | ||
| EG001 | Artificial Tear Formulation 2 | Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear | 0 | 47 | 0 | 47 | ||
| EG002 | Glycerin and Polysorbate 80 Based Artificial Tear | Glycerin and Polysorbate 80 based artificial tear | 0 | 47 | 0 | 47 |
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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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| How moistening/lubricating is drop in the eye? |
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| How clear is vision with drop in the eye? |
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| How much stickiness with drop in the eye? |
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| How much blur with drop in the eye? |
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| How much burning/stinging with drop in the eye? |
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| How much discomfort with drop in the eye? |
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