Phase 3
N=1,454
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01382225 ↗Enrolled (actual)
1,454
Serious AEs
0.1%
Results posted
Jul 2013
Primary outcome: Primary: Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 — 4.9; 4.8; -0.8; -0.7 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sodium Hyaluronate Ophthalmic Solution, 0.18% (Drug); Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 |
4.9; 4.8; -0.8; -0.7 | — |
| PRIMARY Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7 |
8.9; 9.1; -1.6; -1.3 | — |
| SECONDARY Change From Baseline in LGS Total Score at Day 14 |
4.9; 4.8; -1.2; -1.0 | — |
| SECONDARY Change From Baseline in GSF Total Score at Day 14 |
8.9; 9.1; -2.3; -2.2 | — |
| SECONDARY Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score |
4.9; 4.8; -10.0; -10.4; -19.3; -16.1 | — |
| SECONDARY Percentage Change From Baseline in Schirmer I Score |
9.7; 10.1; 52.1; 40.6; 60.3; 47.0 | — |
| SECONDARY Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score |
294.2; 295.8; -18.9; -15.4; -31.6; -26.9 | — |
| SECONDARY Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score |
594.8; 608.4; -26.1; -22.4; -40.1; -36.3 | — |
| SECONDARY Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating |
31.0; 26.5; 42.7; 38.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01382225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.