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Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Carboxymethylcellulose and Glycerin |
|
| 2 | Active Comparator | Polyethylene glycol 400 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubricant Eye Drops (Optive™) | Drug | 1 drop in both eyes as needed for 7 days' |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Frequency of Eye Drop Use Over 1 Week | Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 | Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort. |
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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 |
|---|---|---|---|---|---|---|
| Chevy Chase | Maryland | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | All patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All 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 | Mean Frequency of Eye Drop Use Over 1 Week | Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms. | Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure | Posted | Mean | Standard Deviation | Use per day | 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 | All Patients | All patients |
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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 |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Lubricating Eye Drops (blink® Tears) | Drug | 1 drop in both eyes as needed for 7 days |
|
|
| Baseline, Day 16 |
| Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16 | Percentage of patients who responded "Strongly Agree" and "Agree" to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are "Strongly Agree", "Agree", "Neither Agree or Disagree", "Disagree" and "Strongly Disagree". | Day 16 |
| Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16 | Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2. | Day 16 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Lubricant Eye Drops(blink® Tears)
|
|
| Secondary | Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 | Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort. | Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Day 16 |
|
|
|
| Secondary | Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16 | Percentage of patients who responded "Strongly Agree" and "Agree" to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are "Strongly Agree", "Agree", "Neither Agree or Disagree", "Disagree" and "Strongly Disagree". | Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure | Posted | Number | Percentage of Patients | Day 16 |
|
|
|
| Secondary | Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16 | Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2. | Intent to Treat; defined as all randomized (started study) patients. | Posted | Number | Number of patients | Day 16 |
|
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|
| 0 |
| 51 |
| 0 |
| 51 |
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.
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |