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Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01382225
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : July 8, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye Syndrome
Interventions Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%
Other: Vehicle
Enrollment 1936
Recruitment Details Subjects were recruited from 56 investigative sites in the United States.
Pre-assignment Details 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).
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description 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 Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Period Title: Overall Study
Started 725 729
Completed 711 722
Not Completed 14 7
Reason Not Completed
Adverse Event             3             2
Protocol Violation             2             1
Subject Withdrew Consent             5             2
Other             4             2
Arm/Group Title Sodium Hyaluronate Vehicle Total
Hide Arm/Group Description 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 Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days Total of all reporting groups
Overall Number of Baseline Participants 723 727 1450
Hide Baseline Analysis Population Description
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.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 723 participants 727 participants 1450 participants
18-64 years 402 392 794
≥65 years 321 335 656
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 723 participants 727 participants 1450 participants
Female
590
  81.6%
594
  81.7%
1184
  81.7%
Male
133
  18.4%
133
  18.3%
266
  18.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 723 participants 727 participants 1450 participants
723 727 1450
1.Primary Outcome
Title Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.9  (2.2) 4.8  (2.1)
Change from Baseline at Day 7 -0.8  (1.8) -0.7  (1.6)
2.Primary Outcome
Title Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 8.9  (2.3) 9.1  (2.3)
Change from Baseline at Day 7 -1.6  (2.6) -1.3  (2.4)
3.Secondary Outcome
Title Change From Baseline in LGS Total Score at Day 14
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.9  (2.2) 4.8  (2.1)
Change from Baseline at Day 14 -1.2  (2.0) -1.0  (1.8)
4.Secondary Outcome
Title Change From Baseline in GSF Total Score at Day 14
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 8.9  (2.3) 9.1  (2.3)
Change from Baseline at Day 14 -2.3  (2.8) -2.2  (2.8)
5.Secondary Outcome
Title Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Percent change
Baseline 4.9  (2.1) 4.8  (2.0)
Change from Baseline at Day 7 -10.0  (40.3) -10.4  (36.9)
Change from Baseline at Day 14 -19.3  (46.6) -16.1  (44.1)
6.Secondary Outcome
Title Percentage Change From Baseline in Schirmer I Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Percent change
Baseline 9.7  (8.6) 10.1  (8.5)
Change from Baseline at Day 7 52.1  (195.2) 40.6  (139.8)
Change from Baseline at Day 14 60.3  (273.2) 47.0  (170.7)
7.Secondary Outcome
Title Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Percent change
Baseline 294.2  (80.8) 295.8  (82.5)
Change from Baseline at Day 7 -18.9  (34.1) -15.4  (34.5)
Change from Baseline at Day 14 -31.6  (37.7) -26.9  (38.4)
8.Secondary Outcome
Title Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Mean (Standard Deviation)
Unit of Measure: Percentage change
Baseline 594.8  (249.9) 608.4  (258.0)
Change from Baseline at Day 7 -26.1  (43.6) -22.4  (43.2)
Change from Baseline at Day 14 -40.1  (44.9) -36.3  (44.4)
9.Secondary Outcome
Title Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description:
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Number of Participants Analyzed 643 648
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 7 31.0 26.5
Day 14 42.7 38.0
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Hyaluronate Vehicle
Hide Arm/Group Description Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
All-Cause Mortality
Sodium Hyaluronate Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Hyaluronate Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   1/723 (0.14%)   1/727 (0.14%) 
Gastrointestinal disorders     
Gastritis 1 [1]  1/723 (0.14%)  0/727 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia 1 [1]  0/723 (0.00%)  1/727 (0.14%) 
Psychiatric disorders     
Mania 1 [1]  0/723 (0.00%)  1/727 (0.14%) 
1
Term from vocabulary, MedDRA 14.0
[1]
Not related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sodium Hyaluronate Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/723 (0.00%)   0/727 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Michela Montecchi-Palmer, Clinical Project Lead
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01382225     History of Changes
Other Study ID Numbers: C-09-045
First Submitted: June 9, 2011
First Posted: June 27, 2011
Results First Submitted: May 20, 2013
Results First Posted: July 8, 2013
Last Update Posted: July 8, 2013