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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01382225
First received: June 9, 2011
Last updated: May 20, 2013
Last verified: May 2013

June 9, 2011
May 20, 2013
July 2011
May 2012   (final data collection date for primary outcome measure)
  • Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]
    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.
  • Change from baseline in lissamine green staining total score [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Change from baseline in global symptom frequency total score [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01382225 on ClinicalTrials.gov Archive Site
  • Change From Baseline in LGS Total Score at Day 14 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, up to Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, up to Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, up to Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, up to Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Up to Day 14 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye Syndrome
  • Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%
  • Other: Vehicle
    Inactive ingredients used as run-in and placebo comparator
  • Experimental: Sodium Hyaluronate
    Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
    Intervention: Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%
  • Placebo Comparator: Vehicle
    Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days
    Intervention: Other: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1936
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01382225
C-09-045
No
Alcon Research
Alcon Research
Not Provided
Study Director: Michela Montecchi-Palmer, BS Alcon Research
Alcon Research
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP