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This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OM3 Tear | Experimental | Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
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| REFRESH OPTIVE® ADVANCED | Active Comparator | Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop | Drug | Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement. | Baseline, Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tear Break-up Time (TBUT) | 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. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a 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 |
|---|---|---|---|---|---|---|
| The Private Practice of Milton Hom, OD | Azusa | California | 91702 | United States | ||
| Havana Research Institute LLC |
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| Label | URL |
|---|---|
| More Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | OM3 Tear | Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| FG001 | REFRESH OPTIVE® ADVANCED |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carboxymethylcellulose Sodium 0.5% | Drug | Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
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| Baseline, Day 90 |
| Change From Baseline in Corneal Staining Score | Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Day 90 |
| Change From Baseline in Conjunctival Staining Score | Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Day 90 |
| Change From Baseline in the Schirmer Test | The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 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 defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement). | Baseline, Day 90 |
| Burbank |
| California |
| 91506 |
| United States |
| Lugene Eye Institute | Glendale | California | 91204 | United States |
| Eric M. White, OD, INC | San Diego | California | 92123 | United States |
| Moyes Eye Center, PC | Kansas City | Missouri | 64154 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| Charlotte Eye Ear Nose | Charlotte | North Carolina | 28210 | United States |
| Scott and Christie and Associate | Cranberry Township | Pennsylvania | 16066 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Department of Optometry & Vision Sciences, The University of Melbourne | Parkville | VIC 3010 | Australia |
| Prof. M.T. Coroneo Pty. Ltd. | Randwick | NSW 2031 | Australia |
| The University of New South Wales School of Optometry and Vision Science | Sydney | NSW 2052 | Australia |
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | OM3 Tear | Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| BG001 | REFRESH OPTIVE® ADVANCED | Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
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| 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 the Ocular Surface Disease Index© (OSDI©) Score | The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. 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 90 |
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| Secondary | Change From Baseline in Tear Break-up Time (TBUT) | 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. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening. | ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | seconds | Baseline, Day 90 |
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| Secondary | Change From Baseline in Corneal Staining Score | Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 90 |
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| Secondary | Change From Baseline in Conjunctival Staining Score | Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 90 |
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| Secondary | Change From Baseline in the Schirmer Test | The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 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 defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement). | ITT population included all randomized participants. "n" is the number of participants in the category with data available at the given time-point. | Posted | Mean | Standard Deviation | mm | Baseline, Day 90 |
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120 Days
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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 | OM3 Tear | Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | 1 | 120 | 0 | 120 | ||
| EG001 | REFRESH OPTIVE® ADVANCED | Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | 1 | 122 | 0 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | 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 | 1-877-277-8566 | IR-CTRegistration@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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