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

NCT01382225 | Completed Phase 3 Results

• 1 other identifier: C-09-045
• Study Type: interventional
• Target: 1,936
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye Syndrome

Keywords

Dry eyes; Ocular discomfort

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Day 7

• 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.

  Baseline, Day 7

Secondary Outcomes (7)

• Change From Baseline in LGS Total Score at Day 14

  Baseline, Day 14

• Change From Baseline in GSF Total Score at Day 14

  Baseline, Day 14

• Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score

  Baseline, up to Day 14

• Percentage Change From Baseline in Schirmer I Score

  Baseline, up to Day 14

• Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score

  Baseline, up to Day 14

Study Arms (2)

Sodium Hyaluronate

EXPERIMENTAL

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%

Vehicle

PLACEBO COMPARATOR

Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Other: Vehicle

Interventions

Sodium Hyaluronate Ophthalmic Solution, 0.18% DRUG

Sodium Hyaluronate

Vehicle OTHER

Inactive ingredients used as run-in and placebo comparator

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of dry eyes for at least 3 months.
• Ocular discomfort due to dry eyes.
• Presence of corneal and conjunctival staining.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Michela Montecchi-Palmer, Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Michela Montecchi-Palmer, BS

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 8, 2013
• Results First Posted: July 8, 2013

Record last verified: 2013-05