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This is an open label study of Optive eyedrops and gel combination for day and night dry eye management
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optive® Fusion + Optive® Gel Drop | Experimental | Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. The treatment regimen will be used for one month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optive® Fusion + Optive® Gel Drop | Device | Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. | Change from baseline to (day 30 +/- 3 days) |
| Measured Lissamine Green Bulbar Conjunctival Staining (mm2) | The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2). | Change from baseline to (day 30 +/- 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms. | Baseline (day 0) to (day 30 +/- 3 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameena Haque | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Technology Group - international | London | SW1E 6AU | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Optive® Fusion™ and Optive® Gel Drop | A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Optive® Fusion™ and Optive® Gel Drop | A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. |
| 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 |
| 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 (OSDI) Total Score | A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. | Posted | Mean | Standard Deviation | Scores on a scale | Change from baseline to (day 30 +/- 3 days) |
|
Baseline (day 0) to (day 30 +/- 3 days)
Did not meet 5% threshold
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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 | Optive® Fusion™ and Optive® Gel Drop | A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Allergan | 714-246-4500 | CTRegistration@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2017 | Oct 22, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2017 | Oct 22, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Data not collected for these data points. | Count of Participants | Participants |
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| Primary | Measured Lissamine Green Bulbar Conjunctival Staining (mm2) | The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2). | Posted | Mean | Standard Deviation | mm2 | Change from baseline to (day 30 +/- 3 days) |
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| Secondary | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (day 0) to (day 30 +/- 3 days) |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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.
(Note that this agreement language may appear in the study protocol)
| Superiority |
| Title | Measurements |
|---|---|
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| Dry at Day 30 |
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| Gritty at Baseline |
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| Gritty at Day 30 |
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| Vision at Baseline |
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| Vision at Day 30 |
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| Superiority |
| Gritty | t-test, 1 sided | <0.001 | Superiority |
| Vision | t-test, 1 sided | <0.001 | Superiority |