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The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Hyaluronate | Experimental | Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
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| Vehicle | Placebo Comparator | Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate Ophthalmic Solution, 0.18% | Drug |
| ||
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 | The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement. | Baseline, Day 7 |
| Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement. | Baseline, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in LGS Total Score at Day 14 | The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement. | Baseline, Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michela Montecchi-Palmer, BS | Alcon Research | Study Director |
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Of the 1936 subjects enrolled, 268 did not qualify for vehicle run-in and were exited as screen failures. Of the 1668 subjects receiving vehicle run-in, 214 did not qualify for randomization and were exited as screen failures. This reporting group includes the 1454 subjects randomized to receive treatment at Baseline Visit (Day 0).
Subjects were recruited from 56 investigative sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Hyaluronate | Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
| FG001 | Vehicle | Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of the 1454 subjects randomized, 4 withdrew participation prior to exposure to test article. This reporting group includes the 1450 subjects exposed to test article.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Hyaluronate | Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
| BG001 | Vehicle | Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
| 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 |
| 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 Lissamine Green Staining (LGS) Total Score at Day 7 | The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement. | Modified Intent-to-Treat (mITT): The set of all randomized subjects who received at least one administration of the allocated product, had baseline efficacy measurement, had at least 1 post-baseline measurement and received the correct formulation of the lissamine green solution. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 7 |
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Adverse events were collected for the duration of the study. The safety population includes all randomized subjects who receive exposure to study medication or had potential exposure.
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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 | Sodium Hyaluronate | Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Not related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michela Montecchi-Palmer, Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Other |
Inactive ingredients used as run-in and placebo comparator |
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| Change From Baseline in GSF Total Score at Day 14 | The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement. | Baseline, Day 14 |
| Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score | The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement. | Baseline, up to Day 14 |
| Percentage Change From Baseline in Schirmer I Score | The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement. | Baseline, up to Day 14 |
| Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score | The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement. | Baseline, up to Day 14 |
| Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score | For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement. | Baseline, up to Day 14 |
| Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating | The subject was asked on a questionnaire, "Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life," and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement. | Baseline, Up to Day 14 |
| Subject Withdrew Consent |
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| Other |
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| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Vehicle | Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
|
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| Primary | Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement. | Modified Intent-to-Treat | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 7 |
|
|
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| Secondary | Change From Baseline in LGS Total Score at Day 14 | The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement. | Modified Intent-to-Treat | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 14 |
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| Secondary | Change From Baseline in GSF Total Score at Day 14 | The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement. | Modified Intent-to-Treat | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 14 |
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| Secondary | Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score | The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement. | Modified Intent-to-Treat | Posted | Mean | Standard Deviation | Percent change | Baseline, up to Day 14 |
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| Secondary | Percentage Change From Baseline in Schirmer I Score | The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement. | Modified Intent-to-Treat | Posted | Mean | Standard Deviation | Percent change | Baseline, up to Day 14 |
|
|
|
| Secondary | Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score | The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement. | Modified Intent-to-Treat | Posted | Mean | Standard Deviation | Percent change | Baseline, up to Day 14 |
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| Secondary | Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score | For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement. | Modified Intent-to-Treat | Posted | Mean | Standard Deviation | Percentage change | Baseline, up to Day 14 |
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| Secondary | Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating | The subject was asked on a questionnaire, "Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life," and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement. | Modified Intent-to-Treat | Posted | Number | Percentage of Participants | Baseline, Up to Day 14 |
|
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| 1 |
| 723 |
| 0 |
| 723 |
| EG001 | Vehicle | Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days | 1 | 727 | 0 | 727 |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Not related |
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| Mania | Psychiatric disorders | MedDRA 14.0 | Not related |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Change from Baseline at Day 14 |
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| Change from Baseline at Day 14 |
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| Change from Baseline at Day 14 |
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| Change from Baseline at Day 14 |
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