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This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Experimental | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
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| Carboxymethylcellulose Based Eye Drop Formulation B | Experimental | Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
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| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Active Comparator | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
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| Carboxymethylcellulose Based Lubricant Eye Drops | Active Comparator | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Drug | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement. | Baseline, Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tear Break-up Time | Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement. | Baseline, Day 30 |
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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 |
|---|---|---|---|---|---|---|
| Petaluma | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25931806 | Background | Simmons PA, Carlisle-Wilcox C, Vehige JG. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial. Clin Ophthalmol. 2015 Apr 15;9:657-64. doi: 10.2147/OPTH.S74849. eCollection 2015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| FG001 | Carboxymethylcellulose Based Eye Drop Formulation B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carboxymethylcellulose Based Eye Drop Formulation B | Drug | Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
|
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| Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops | Drug | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
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| Carboxymethylcellulose Based Lubricant Eye Drops | Drug | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
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| Change From Baseline in Corneal Staining | 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 a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement). | Baseline, Day 30 |
| Change From Baseline in Conjunctival Staining | 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. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement). | Baseline, Day 30 |
| Change From Baseline in Schirmer Test Results | The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement). | Baseline, Day 30 |
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| FG002 | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| FG003 | Carboxymethylcellulose Based Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| BG001 | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| BG002 | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| BG003 | Carboxymethylcellulose Based Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| BG004 | 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 Ocular Surface Disease Index© Questionnaire Score | The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement. | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 30 |
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| Secondary | Change From Baseline in Tear Break-up Time | Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement. | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | Seconds | Baseline, Day 30 |
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| Secondary | Change From Baseline in Corneal Staining | 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 a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement). | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 30 |
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| Secondary | Change From Baseline in Conjunctival Staining | 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. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement). | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | Score on as scale | Baseline, Day 30 |
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| Secondary | Change From Baseline in Schirmer Test Results | The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement). | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | millimeters | Baseline, Day 30 |
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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 Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | 1 | 105 | 0 | 105 | ||
| EG001 | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | 0 | 51 | 0 | 51 | ||
| EG002 | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | 0 | 103 | 0 | 103 | ||
| EG003 | Carboxymethylcellulose Based Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | 1 | 56 | 0 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | 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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| 30 to 40 years |
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| >40 years |
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| Male |
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| Change from baseline at Day 30 |
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| OG003 | Carboxymethylcellulose Based Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
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Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| OG003 | Carboxymethylcellulose Based Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
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Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| OG003 | Carboxymethylcellulose Based Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
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| OG003 | Carboxymethylcellulose Based Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
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