Back to resultsSodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sodium Hyaluronate Ophthalmic Solution, 0.18%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry eyes, Ocular discomfort
Eligibility Criteria
Inclusion Criteria:
- Documented history of dry eyes for at least 3 months.
- Ocular discomfort due to dry eyes.
- Presence of corneal and conjunctival staining.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Women who are pregnant or lactating.
- Contact lens wear within 1 week before Screening and during the study.
- Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
- Punctal plugs or punctal occlusion initiated within 3 months of screening
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium Hyaluronate
Vehicle
Arm Description
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01382225
Brief Title
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
Official Title
A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry eyes, Ocular discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1936 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Hyaluronate
Arm Type
Experimental
Arm Description
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate Ophthalmic Solution, 0.18%
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
Inactive ingredients used as run-in and placebo comparator
Primary Outcome Measure Information:
Title
Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7
Description
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.
Time Frame
Baseline, Day 7
Title
Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7
Description
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.
Time Frame
Baseline, Day 7
Secondary Outcome Measure Information:
Title
Change From Baseline in LGS Total Score at Day 14
Description
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.
Time Frame
Baseline, Day 14
Title
Change From Baseline in GSF Total Score at Day 14
Description
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.
Time Frame
Baseline, Day 14
Title
Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score
Description
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.
Time Frame
Baseline, up to Day 14
Title
Percentage Change From Baseline in Schirmer I Score
Description
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.
Time Frame
Baseline, up to Day 14
Title
Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score
Description
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.
Time Frame
Baseline, up to Day 14
Title
Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score
Description
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.
Time Frame
Baseline, up to Day 14
Title
Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating
Description
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.
Time Frame
Baseline, Up to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented history of dry eyes for at least 3 months.
Ocular discomfort due to dry eyes.
Presence of corneal and conjunctival staining.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Women who are pregnant or lactating.
Contact lens wear within 1 week before Screening and during the study.
Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
Punctal plugs or punctal occlusion initiated within 3 months of screening
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michela Montecchi-Palmer, BS
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
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