Phase 2
N=124
ESBA105 in Patients With Severe Dry Eye
Eyes Dry Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01338610 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 — 63.8773; 70.2194 Units on a scale x days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ESBA105 ophthalmic solution (Biological); ESBA105 vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 |
63.8773; 70.2194 | — |
Summary
The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.
Eligibility Criteria
Inclusion Criteria
- Ongoing physician diagnosis of dry eye for at least 6 months.
- Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
- Experience persistent ocular discomfort.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Contact lens wearers.
- Severe Sjogren's Syndrome.
- History of corneal surgery including refractive surgeries.
- Intraocular surgery within 6 months of Visit 1.
- Intraocular or periocular injection within 6 months of Visit 1.
- Lid function abnormalities.
- Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
- Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1.
- Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01338610). 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.