Trial · NCT01382225
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
NCT01382225, Phase 3, Completed, Alcon Research; results first posted 2013-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome. Trials, record NCT01382225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01382225
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
- NCT number
- NCT01382225
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,936 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Dry Eye Syndrome
- Interventions
- Sodium Hyaluronate Ophthalmic Solution, 0.18%, Vehicle
- First posted
- 2011-06-27
- Last updated
- 2013-07-08
- Results first posted
- 2013-07-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 | Baseline, 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. |
| Primary | Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | Baseline, 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. |
| Secondary | Change From Baseline in LGS Total Score at Day 14 | Baseline, 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. |
| Secondary | Change From Baseline in GSF Total Score at Day 14 | Baseline, 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. |
| Secondary | Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score | Baseline, up to Day 14 | 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. |
| Secondary | Percentage Change From Baseline in Schirmer I Score | Baseline, up to Day 14 | 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. |
| Secondary | Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score | Baseline, up to Day 14 | 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. |
| Secondary | Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score | Baseline, up to Day 14 | 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. |
| Secondary | Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating | Baseline, Up to Day 14 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 | Baseline, Day 7 | 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. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | Baseline, Day 7 | Modified Intent-to-Treat | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in LGS Total Score at Day 14 | Baseline, Day 14 | Modified Intent-to-Treat | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in GSF Total Score at Day 14 | Baseline, Day 14 | Modified Intent-to-Treat | Units on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score | Baseline, up to Day 14 | Modified Intent-to-Treat | Percent change | MEAN |
| SECONDARY | Percentage Change From Baseline in Schirmer I Score | Baseline, up to Day 14 | Modified Intent-to-Treat | Percent change | MEAN |
| SECONDARY | Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score | Baseline, up to Day 14 | Modified Intent-to-Treat | Percent change | MEAN |
| SECONDARY | Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score | Baseline, up to Day 14 | Modified Intent-to-Treat | Percentage change | MEAN |
| SECONDARY | Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating | Baseline, Up to Day 14 | Modified Intent-to-Treat | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 | Sodium Hyaluronate | Baseline | 4.9 | Standard Deviation 2.2 | Units on a scale |
| Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 | Vehicle | Baseline | 4.8 | Standard Deviation 2.1 | Units on a scale |
| Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 | Sodium Hyaluronate | Change from Baseline at Day 7 | -0.8 | Standard Deviation 1.8 | Units on a scale |
| Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 | Vehicle | Change from Baseline at Day 7 | -0.7 | Standard Deviation 1.6 | Units on a scale |
| Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | Sodium Hyaluronate | Baseline | 8.9 | Standard Deviation 2.3 | Units on a scale |
| Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | Vehicle | Baseline | 9.1 | Standard Deviation 2.3 | Units on a scale |
| Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | Sodium Hyaluronate | Change from Baseline at Day 7 | -1.6 | Standard Deviation 2.6 | Units on a scale |
| Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 | Vehicle | Change from Baseline at Day 7 | -1.3 | Standard Deviation 2.4 | Units on a scale |
| Change From Baseline in LGS Total Score at Day 14 | Sodium Hyaluronate | Baseline | 4.9 | Standard Deviation 2.2 | Units on a scale |
| Change From Baseline in LGS Total Score at Day 14 | Vehicle | Baseline | 4.8 | Standard Deviation 2.1 | Units on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Hyaluronate | 725 | |
| Overall Study | STARTED | Vehicle | 729 | |
| Overall Study | COMPLETED | Sodium Hyaluronate | 711 | |
| Overall Study | COMPLETED | Vehicle | 722 | |
| Overall Study | NOT COMPLETED | Sodium Hyaluronate | 14 | |
| Overall Study | NOT COMPLETED | Vehicle | 7 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Gastritis | Gastrointestinal disorders | Sodium Hyaluronate | 1 | 723 | |
| serious | Gastritis | Gastrointestinal disorders | Vehicle | 0 | 727 | |
| serious | Hyponatraemia | Metabolism and nutrition disorders | Sodium Hyaluronate | 0 | 723 | |
| serious | Hyponatraemia | Metabolism and nutrition disorders | Vehicle | 1 | 727 | |
| serious | Mania | Psychiatric disorders | Sodium Hyaluronate | 0 | 723 | |
| serious | Mania | Psychiatric disorders | Vehicle | 1 | 727 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Hyaluronate | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | Sodium Hyaluronate | 0 | 723 |
| Total, other adverse events | Vehicle | 0 | 727 |
| Total, serious adverse events | Sodium Hyaluronate | 1 | 723 |
| Total, serious adverse events | Vehicle | 1 | 727 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sodium Hyaluronate vs Vehicle: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01382225
GET https://conductscience.org/api/trials/v1/NCT01382225/results?page=2