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This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) |
|
| 2 | Active Comparator | sodium hyaluronate 0.18% (VISMED® Multi) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD) | Drug | One drop in each eye three to six times daily, as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Global Ocular Staining Score at Day 35 | Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst). | Baseline, Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms. |
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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 |
|---|---|---|---|---|---|---|
| Paris | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) | carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) |
| FG001 | Sodium Hyaluronate 0.18% (VISMED® Multi) | sodium hyaluronate 0.18% (VISMED® Multi) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) | carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) |
| BG001 | Sodium Hyaluronate 0.18% (VISMED® Multi) | sodium hyaluronate 0.18% (VISMED® Multi) |
| 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 | Change From Baseline in Global Ocular Staining Score at Day 35 | Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst). | Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35. | Posted | Mean | Standard Deviation | Number on a scale (score) | Baseline, Day 35 |
|
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The safety population included all subjects who were randomized and treated with at least one dose of the study product. (Note: 3 randomized subjects in the VISMED® Multi group did not receive a dose and were not included in the safety population).
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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 0.5% and Glycerin 0.9% (OPTIVE® MD) | carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
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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 |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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| ID | Term |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| D005990 | Glycerol |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
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| sodium hyaluronate 0.18% (VISMED® Multi) | Drug | One drop in each eye three to six times daily, as needed |
|
|
| Baseline, Day 35 |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Sodium Hyaluronate 0.18% (VISMED® Multi) |
sodium hyaluronate 0.18% (VISMED® Multi) |
|
|
| Secondary | Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms. | Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35. | Posted | Mean | Standard Deviation | Number on a scale (score) | Baseline, Day 35 |
|
|
|
| 1 |
| 41 |
| 0 |
| 41 |
| EG001 | Sodium Hyaluronate 0.18% (VISMED® Multi) | sodium hyaluronate 0.18% (VISMED® Multi) | 1 | 38 | 0 | 38 |
| Amyotrophic Lateral Sclerosis | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
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 at least 30 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D002241 |
| Carbohydrates |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D006025 | Glycosaminoglycans |