N/A
N=288
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01010282 ↗Enrolled (actual)
288
Serious AEs
2.1%
Results posted
Dec 2011
Primary outcome: Primary: Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90 — 2.7; 2.8; 2.8; -0.7 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glycerin and Polysorbate 80 based artificial tear (Drug); Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear (Drug); Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90 |
2.7; 2.8; 2.8; -0.7; -0.7; -0.7 | — |
| SECONDARY Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90 |
33.6; 35.1; 37.3; -7.2; -10.6; -9.1 | — |
| SECONDARY Change From Baseline in Tear Break-up Time (TBUT) at Day 90 |
4.90; 5.04; 5.09; 1.49; 2.02; 1.81 | — |
| SECONDARY Change From Baseline in Corneal Staining at Day 90 |
4.2; 4.2; 4.5; 0.2; -0.5; 0.8 | — |
| SECONDARY Change From Baseline in Conjunctival Staining Severity Score at Day 90 |
5.1; 4.9; 5.2; -0.5; -0.7; -0.7 | — |
Summary
This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.
Eligibility Criteria
Inclusion Criteria
- Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
- Ability/agreement to wear habitual correction (glasses) during study period
Exclusion Criteria
- Known allergy or sensitivity to the study product(s) or its components
- Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
- Chronic use of systemic medications which may affect a dry eye condition
- Active ocular allergy or infection
- Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
- Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.
Data sourced from ClinicalTrials.gov (NCT01010282). 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.