Status:
COMPLETED
Effects of a PF Ophthalmic Solution Containing HA0.4% and TAU 0.5%
Lead Sponsor:
Fondazione G.B. Bietti, IRCCS
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Eligible patients underwent evaluation of ocular surface parameters by Ocular Surface Disease Index (OSDI) and Glaucoma Symptom Scale (GSS) questionnaires, Break Up Time test (BUT), Schirmer I test, c...
Detailed Description
At the screening visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, IOP measurement using Goldmann applana...
Eligibility Criteria
Inclusion
- Diagnosis of glaucoma with an ongoing topical therapy with two or more preserved ocular hypotensive eye-drops per day for at least two years.
Exclusion
- Best corrected visual acuity ≤ 20/40
- History of active or past ophthalmological diseases different than glaucoma
- Contraindications to use of topical solution components used in this study
- Current use of contact lenses
- Current use or use in the past 6 months of ocular medications other than hypotensive eye-drops
- Systemic treatments known to affect tear secretion
- Any history or slit lamp evidence of eye surface diseases different from dry eye
- History of ocular trauma
- Surgery or laser treatments
- Rheumatologic and autoimmune diseases
- Diabetes
- Peripheral neuropathies
- Use of systemic steroids or immunosuppressants
Key Trial Info
Start Date :
December 19 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03480295
Start Date
December 19 2016
End Date
April 27 2017
Last Update
March 29 2018
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