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Effects of a PF Ophthalmic Solution Containing HA0.4% and TAU 0.5%

NCT03480295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-03-29

No results posted yet for this study

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, corneal and conjunctival staining (Oxford scale) and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering Gmbh, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (Group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID, (Group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days.

Conditions

Interventions

DEVICE

Hyaluronic acid 0.4% and Taurine 0.5%

4 drops /day in addition to the ongoing glaucoma treatment

DEVICE

Hyaluronic acid 0.2%

4 drops /day in addition to the ongoing glaucoma treatment

Sponsors & Collaborators

  • Fondazione G.B. Bietti, IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2017-04-27
Completion
2017-04-27

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480295 on ClinicalTrials.gov