Phase 4
N=70
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00938704 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 — 56.06; 54.292; -27.048; -28.303 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- carboxymethylcellulose 0.5% +glycerin 0.9% (Drug); sodium hyaluronate 0.18% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 |
56.06; 54.292; -27.048; -28.303 | — |
| SECONDARY Change From Baseline in Tear Breakup Time (TBUT) at Week 2 |
6.501; 5.914; 2.919; 2.538 | — |
| SECONDARY Change From Baseline in Corneal Staining at Week 2 |
1.818; 1.608; -1.288; -1.23 | — |
| SECONDARY Change From Baseline in Conjunctival Staining (Temporal) at Week 2 |
1.818; 1.919; -1.152; -1.216 | — |
| SECONDARY Change From Baseline in Conjunctival Staining (Nasal) at Week 2 |
1.758; 2.000; -1.061; -1.459 | — |
Summary
To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.
Eligibility Criteria
Inclusion Criteria
- Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
- Be likely to complete the entire course of study and to comply with appropriate instructions
Exclusion Criteria
- Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
- Have uncontrolled systemic disease
- Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
- Have anticipated contact lens wear during the study
- Have an active ocular infection
Data sourced from ClinicalTrials.gov (NCT00938704). 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.