Phase 4
Completed N=82
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Dry Eye Syndromes · Keratoconjunctivitis Sicca
Source: ClinicalTrials.gov NCT00987727 ↗
Enrolled (actual)
82
Serious AEs
2.5%
Results posted
Sep 2011
Primary outcomePrimary: Change From Baseline in Global Ocular Staining Score at Day 35 — 5.4; 5.9; -1.8; -1.8 Number on a scale (score)
Summary
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Global Ocular Staining Score at Day 35 |
5.4; 5.9; -1.8; -1.8 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 |
49.05; 51.98; -13.58; -13.66 | — |
Eligibility Criteria
Inclusion Criteria
- Have been using artificial tears for at least 3 months prior to study inclusion
- Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
- Having moderate to severe symptoms suggestive of dry eye
Exclusion Criteria
- Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
- Moderate to severe blepharitis
- History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
- History or active signs of ocular allergic disease or ocular herpes within the last year
- History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
Data sourced from ClinicalTrials.gov (NCT00987727). 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. Informational only — not medical advice.