Phase 3
Completed N=305
Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT01294384 ↗
Enrolled (actual)
305
Serious AEs
1.6%
Results posted
Nov 2013
Primary outcomePrimary: Change From Baseline in Ocular Surface Disease Index© (OSDI) Score — 36.83; 38.51; 38.86; -14.72 Score on a scale
Summary
This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Surface Disease Index© (OSDI) Score |
36.83; 38.51; 38.86; -14.72; -12.75; -14.49 | — |
| SECONDARY Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness |
61.1; 64.0; 60.9; -24.2; -19.2; -20.9 | — |
| SECONDARY Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast) |
5.0; 8.0; 5.8; 22.0; 21.0; 30.8 | — |
| SECONDARY Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast) |
7.0; 6.0; 4.8; 15.0; 20.0; 22.1 | — |
| SECONDARY Change From Baseline in Tear Break-Up Time (TBUT) |
5.24; 5.22; 5.05; 1.65; 1.97; 1.27 | — |
| SECONDARY Change From Baseline in Corneal Staining |
6.4; 6.1; 5.8; -2.3; -2.0; -1.2 | — |
| SECONDARY Change From Baseline in Conjunctival Staining |
8.0; 7.8; 8.2; -2.7; -2.4; -2.7 | — |
| SECONDARY Change From Baseline in Schirmer Test |
8.7; 10.3; 8.9; 1.2; 1.5; 1.1 | — |
Eligibility Criteria
Inclusion Criteria
- Current use of an artificial tear product at least twice daily for at least 3 months, on average
- Ability/agreement to continue wearing existing spectacle correction (glasses) during study
Exclusion Criteria
- Anticipated contact lens wear during study or contact lens use within 6 months
- Active ocular infection or allergy
- Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
- Use of any topical cyclosporine products within 3 months
Data sourced from ClinicalTrials.gov (NCT01294384). 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.