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

NCT03480295 | Completed

• 1 other identifier: IRCCS-Fondazione GB Bietti
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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, 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

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Change from baseline of conjunctival goblet cells (CGC) density after 30 and 90 days

  Density of CGC was measured by means of conjunctival confocal microscopy

  Baseline, 30 and 60 days

Study Arms (2)

HA0.4%+TAU0.5%

EXPERIMENTAL

Patients had to administer 4 drops/day of an ophthalmic solution containing hyaluronic acid 0.4% and taurine 0.5% in addition to the ongoing glaucoma treatment

Device: Hyaluronic acid 0.4% and Taurine 0.5%

HA0.2%

ACTIVE COMPARATOR

Patients took 4 drops/day of an ophthalmic solution containing hyaluronic acid 0.2%

Device: Hyaluronic acid 0.2%

Interventions

Hyaluronic acid 0.4% and Taurine 0.5% DEVICE

4 drops /day in addition to the ongoing glaucoma treatment

HA0.4%+TAU0.5%

Hyaluronic acid 0.2% DEVICE

4 drops /day in addition to the ongoing glaucoma treatment

HA0.2%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of glaucoma with an ongoing topical therapy with two or more preserved ocular hypotensive eye-drops per day for at least two years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Related Publications (1)

• Roberti G, Agnifili L, Berardo F, Riva I, Figus M, Manni G, Quaranta L, Oddone F. Prospective, Randomized, Single Masked, Parallel Study Exploring the Effects of a Preservative-Free Ophthalmic Solution Containing Hyaluronic Acid 0.4% and Taurine 0.5% on the Ocular Surface of Glaucoma Patients Under Multiple Long-Term Topical Hypotensive Therapy. Adv Ther. 2018 May;35(5):686-696. doi: 10.1007/s12325-018-0699-8. Epub 2018 Apr 23.

  PMID: 29687335 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 29, 2018
• Study Start: December 19, 2016
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share