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
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndrome
Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%
Other: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1936
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Hyaluronate
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
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
Other: Vehicle
Inactive ingredients used as run-in and placebo comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382225

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Michela Montecchi-Palmer, BS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01382225     History of Changes
Other Study ID Numbers: C-09-045
Study First Received: June 9, 2011
Results First Received: May 20, 2013
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Dry eyes
Ocular discomfort

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014