N/A
N=94
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01863368 ↗Enrolled (actual)
94
Serious AEs
1.0%
Results posted
Jul 2015
Primary outcome: Primary: Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) — -2.2; -1.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preservative-free saline solution eyedrops (Other); Systane® ULTRA lubricant eyedrops (Other); OPTIVE® lubricating eyedrops (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) |
-2.2; -1.7 | — |
| SECONDARY Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) |
31.0; 35.4 | — |
| SECONDARY Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) |
62.2; 55.7 | — |
| SECONDARY Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) |
69.5; 67.1 | — |
Summary
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
Eligibility Criteria
Inclusion Criteria
- Willing and able to attend all study visits.
- Diagnosis of dry eye, as specified in protocol.
- Uses artificial tears, as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Poor visual acuity, as specified in protocol.
- Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
- Any hypersensitivity or allergy to the investigational products or ingredients.
- Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
- Contact lens use within 2 weeks of Screening Visit.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01863368). 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.