GlaucomaNCT03480295
Effects of a PF Ophthalmic Solution Containing HA0.4% and TAU 0.5%
A study testing Hyaluronic acid 0.4% and Taurine 0.5% and Hyaluronic acid 0.2% in people with Glaucoma, run by Fondazione G.B. Bietti, IRCCS.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Hyaluronic acid 0.4% and Taurine 0.5% and Hyaluronic acid 0.2%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2016to 27 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of glaucoma with an ongoing topical therapy with two or more preserved ocular hypotensive eye-drops per day for at least two years.
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Hyaluronic acid 0.4% and Taurine 0.5%, Hyaluronic acid 0.2%
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid 0.4% and Taurine 0.5%Device
4 drops /day in addition to the ongoing glaucoma treatment
Hyaluronic acid 0.2%Device
4 drops /day in addition to the ongoing glaucoma treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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% Receives: Device: Hyaluronic acid 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start19 Dec 2016
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480295
- Sponsor's protocol ID
- IRCCS-Fondazione GB Bietti
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29687335
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03480295
- Acronym / sponsor ID
- IRCCS-Fondazione GB Bietti
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA0.4%+TAU0.5% | Experimental | Device: Hyaluronic acid 0.4% and Taurine 0.5%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 |
| HA0.2% | Active comparator | Device: Hyaluronic acid 0.2%Patients took 4 drops/day of an ophthalmic solution containing hyaluronic acid 0.2% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of glaucoma with an ongoing topical therapy with two or more preserved ocular hypotensive eye-drops per day for at least two years.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid 0.4% and Taurine 0.5%4 drops /day in addition to the ongoing glaucoma treatment | Device | HA0.4%+TAU0.5% |
| Hyaluronic acid 0.2%4 drops /day in addition to the ongoing glaucoma treatment | Device | HA0.2% |
Primary outcome
Change from baseline of conjunctival goblet cells (CGC) density after 30 and 90 days
Time frame: Baseline, 30 and 60 days
Density of CGC was measured by means of conjunctival confocal microscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 29687335Roberti 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.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid 0.4% and Taurine 0.5% and Hyaluronic acid 0.2% in people with Glaucoma, run by Fondazione G.B. Bietti, IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of conjunctival goblet cells (CGC) density after 30 and 90 days (time frame: Baseline, 30 and 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.