Phase 4
Completed N=80
A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
Dry Eye Syndromes · Keratoconjunctivitis Sicca
Source: ClinicalTrials.gov NCT02117687 ↗
Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Feb 2016
Primary outcomePrimary: Change From Baseline in Global Ocular Staining Score in the Study Eye — 5.2; 5.2; -1.5; -1.6 Scores on a Scale
Summary
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Global Ocular Staining Score in the Study Eye |
5.2; 5.2; -2.5; -2.4 | — |
| SECONDARY Change From Baseline in Global Ocular Staining Score in the Study Eye |
5.2; 5.2; -2.5; -2.4 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index© (OSDI) Score |
45.5; 44.4; -10.3; -12.9 | — |
| SECONDARY Change From Baseline in the Schirmer Test in the Study Eye |
11.1; 8.7; 0.1; 1.0 | — |
| SECONDARY Subject Assessment of Dry Eye Symptoms on a 5-Point Scale |
0; 1; 7; 4; 17; 13 | — |
| SECONDARY Subject Global Assessment of Treatment Efficacy on a 5-Point Scale |
0; 0; 0; 3; 12; 11 | — |
| SECONDARY Subject Assessment of Treatment Acceptability on a 5-Point Scale |
14; 8; 12; 10; 6; 9 | — |
| SECONDARY Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale |
13; 8; 17; 19; 5; 4 | — |
| SECONDARY Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye |
5.52; 5.75; 0.6; 0.7 | — |
| SECONDARY Work Productivity and Activity Impairment Questionnaire Score |
3.09; 3.46; 3.91; 4.35; 2.55; 2.33 | — |
| SECONDARY Change From Baseline in Corneal Staining in the Study Eye |
1.7; 1.9; -0.4; -0.7; -0.8; -0.9 | — |
| SECONDARY Change From Baseline in Conjunctival Staining in the Study Eye |
1.7; 1.6; -0.5; -0.5; -0.8; -0.8 | — |
| SECONDARY Conjunctival Hyperaemia in the Study Eye |
8; 8; 13; 11; 13; 10 | — |
| SECONDARY Study Product Use |
3.63; 3.47; 3.77; 3.39; 3.71; 3.42 | — |
Eligibility Criteria
Inclusion Criteria
- Use of artificial tears for dry eye in both eyes for at least 3 months
- Use of preservative-free artificial tears at least twice daily for 2 weeks;
Exclusion Criteria
- Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
- Use of punctal plugs or contact lenses in the last month
- Active ocular allergy within last 2 years
- Best corrected visual acuity (BCVA) less than 20/200 in either eye
Data sourced from ClinicalTrials.gov (NCT02117687). 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.