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

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Hyaluronic acid 0.4% and Taurine 0.5%; Device: Hyaluronic acid 0.2%

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 applanation tonometry, and indirect dilated ophthalmoscopy with a 90 diopters lens. Visual field testing using Humphrey 24-2 SITA-Standard program (Carl Zeiss Meditec, Inc., Dublin, CA 24-2 program) was performed only for those patients with the last exam older than 3 months.

Baseline visit was splitted in two visits scheduled 1 week apart 2 days, to evaluate ocular surface alterations by means of several tests.

To minimize the influence of each test on the subsequent test, we performed first the least invasive and then the most invasive test. During the first baseline visit patients were asked to fill two questionnaires, the Ocular Surface Disease Index (OSDI) and the Glaucoma Symptom Scale (GSS) and then underwent the Break Up Time test (BUT), corneal and conjunctival staining evaluation using Oxford Staining Scheme, and Schirmer I test after 15 minutes of rest. During the second baseline visit, patients underwent conjunctival Confocal Laser Microscopy with the Rostock Module of Cornea of the Heidelberg Retina Tomograph (HRT3, Heidelberg Engineering Gmbh, Heidelberg, Germany).

At the end of the second baseline visit patients were randomized in two groups with a 1:1 ratio according to a computer-generated randomization list.

Group 1 (HA0.4%+TAU0.5%) was asked to self-administer 1 drop four times/day of a preservative-free ophthalmic solution containing 750KDa HA 0.4% and TAU 0.5% in both eyes, while Group 2 (HA0.2%) was asked to self-administer 1 drop four times/day of a preservative-free ophthalmic solution containing only 750KDa HA 0.2%, in addition to the ongoing hypotensive therapy.

Follow-up visits were scheduled at 30 and 90 days and all the exams were repeated in the same order, as they were performed at the baseline visits.

Both eyes were tested but only one randomly selected eye per patient was included in the analysis.

The primary endpoint was the comparison of the changes over time of the CGC density between the two groups. Secondary endpoints were the between groups comparisons of the changes over time of BUT, Schirmer test, conjunctival staining, OSDI score and GSS score.

All clinical measurements as well the statistical analysis were performed by investigators masked for the patients' treatment group.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HA0.4%+TAU0.5%; 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%; 4 drops /day in addition to the ongoing glaucoma treatment
Active Comparator: HA0.2%; Patients took 4 drops/day of an ophthalmic solution containing hyaluronic acid 0.2%	Device: Hyaluronic acid 0.2%; 4 drops /day in addition to the ongoing glaucoma treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione G.B. Bietti, IRCCS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2016
• Primary Completion (Actual): April 27, 2017
• Study Completion (Actual): April 27, 2017

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: IRCCS-Fondazione GB Bietti

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No