Dry EyePhase 4NCT06726525
Hydroxypropyl-methylcellulose and GlicoPro® Eyedrops in the Treatment of Dry Eye Disease: Clinical Study
A Phase 4 study testing HPMC+GlicoPro eyedrops and Hydroxypropyl-methylcellulose in people with Dry Eye, run by University of Milan at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn if Hydroxypropyl-methylcellulose and GlicoPro® eyedrops work to treat mild-to-moderate dry eye disease in adult patients. The main questions it aims to answer are: Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops reduce patients' symptoms? Do… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- HPMC+GlicoPro eyedrops and Hydroxypropyl-methylcellulose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2024to 12 Sep 2024
- Phase
- Phase 4
- 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
- Age >18 years
- Ocular Surface Disease Index (OSDI) >12 AND <65
- Fluorescein breakup time (FBUT) <10 seconds OR (Oxford staining Score >1 AND <4).
Who cannot join
- Systemic or ocular diseases with known effect on tear film and ocular surface
- Systemic or ocular medications with known effect on tear film and ocular surface
- Contact lens wearing,
- Ocular surgery in the 12 months before enrollment
- Known allergy or poor tolerance to any ingredient of the study products
- Presumed poor compliance to study procedures.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ophthalmology Clinic, Dept. of Biomedical Sciences, University of Messina, Messina, Italy
Messina, 98124
About this study
The goal of this clinical trial is to learn if Hydroxypropyl-methylcellulose and GlicoPro® eyedrops work to treat mild-to-moderate dry eye disease in adult patients. The main questions it aims to answer are:
Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops reduce patients' symptoms? Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops increase patients' tear film stability? Researchers will compare Hydroxypropyl-methylcellulose and GlicoPro® eyedrops to Hydroxypropyl-methylcellulose without GlicoPro® eyedrops to see if Hydroxypropyl-methylcellulose and GlicoPro® formulation works better to treat dry eye..
Read more
Participants will
- Take Hydroxypropyl-methylcellulose and GlicoPro® eyedrops or Hydroxypropyl-methylcellulose eyedrops every day for 3 months
- Visit the clinic 3 times in 3 months for checkups and tests
- Conditions
- Dry Eye
- Being tested
- HPMC+GlicoPro eyedrops, Hydroxypropyl-methylcellulose
- Keywords
- dry eye disease, GlicoPro®, Hydroxypropyl-methylcellulose
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPMC+GlicoPro eyedropsDevice
HPMC+GlicoPro eyedrops, artificial tears for dry eye disease
Hydroxypropyl-methylcelluloseDevice
Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease
| Study group | Role | What they receive |
|---|---|---|
| HPMC+GlicoPro Group | Experimental | Not described Receives: Device: HPMC+GlicoPro eyedrops |
| HPMC alone Group | Active comparator | Not described Receives: Device: Hydroxypropyl-methylcellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI) overall treatment effect
OSDI is a standardized questionnaire for dry eye symptoms (Schiffman RM, et al. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. ).
OSDI overall treatment effect (Month 1 and Month 3)
Measured: From enrollment to the end of treatment at 3 months
Symptom Assessment iN Dry Eye (SANDE) overall treatment effect
SANDE is a validated short global dry eye symptom index (Schaumberg DA, et al. Development and validation of a short global dry eye symptom index. Ocul Surf. 2007 Jan;5(1):50-7) SANDE overall treatment effect (Month 1 and Month 3)
Measured: From enrollment to the end of treatment at 3 months
Fluorescein Break-up time (FBUT) overall treatment effect
FBUT is a widely used method to assess tear film stability (Wolffsohn JS, et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. ) FBUT overall treatment effect (Month 1 and Month 3).
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start3 Feb 2024
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
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 Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- FB VISION, Ascoli Piceno, Italy, University of Messina
- Responsible party
- Principal investigator, Edoardo Villani, University of Milan
- Investigators
- Edoardo Villani, MD, Study director, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726525
- Sponsor's protocol ID
- Prot. 20-22
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro(R) Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther. 2025 Apr;14(4):787-803. doi: 10.1007/s40123-025-01101-6. Epub 2025 Mar 1.
PubMed 40024993
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxypropyl-methylcellulose and GlicoPro® Eyedrops in the Treatment of Dry Eye Disease: Clinical Study
- ClinicalTrials.gov ID
- NCT06726525
- Acronym / sponsor ID
- Prot. 20-22
- Conditions
- Dry Eye
- Keywords
- dry eye disease, GlicoPro®, Hydroxypropyl-methylcellulose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- FB VISION, Ascoli Piceno, Italy, University of Messina
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 10 Dec 2024 (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.
The goal of this clinical trial is to learn if Hydroxypropyl-methylcellulose and GlicoPro® eyedrops work to treat mild-to-moderate dry eye disease in adult patients. The main questions it aims to answer are:
Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops reduce patients' symptoms? Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops increase patients' tear film stability? Researchers will compare Hydroxypropyl-methylcellulose and GlicoPro® eyedrops to Hydroxypropyl-methylcellulose without GlicoPro® eyedrops to see if Hydroxypropyl-methylcellulose and GlicoPro® formulation works better to treat dry eye..
Participants will
- Take Hydroxypropyl-methylcellulose and GlicoPro® eyedrops or Hydroxypropyl-methylcellulose eyedrops every day for 3 months
- Visit the clinic 3 times in 3 months for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPMC+GlicoPro Group | Experimental | Device: HPMC+GlicoPro eyedrops |
| HPMC alone Group | Active comparator | Device: Hydroxypropyl-methylcellulose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Ocular Surface Disease Index (OSDI) >12 AND <65
- Fluorescein breakup time (FBUT) <10 seconds OR (Oxford staining Score >1 AND <4).
Key exclusion criteria (6 listed)
- Systemic or ocular diseases with known effect on tear film and ocular surface
- Systemic or ocular medications with known effect on tear film and ocular surface
- Contact lens wearing,
- Ocular surgery in the 12 months before enrollment
- Known allergy or poor tolerance to any ingredient of the study products
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 |
|---|---|---|
| HPMC+GlicoPro eyedropsHPMC+GlicoPro eyedrops, artificial tears for dry eye disease | Device | HPMC+GlicoPro Group |
| Hydroxypropyl-methylcelluloseHydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease | Device | HPMC alone Group |
Primary outcome
Ocular Surface Disease Index (OSDI) overall treatment effect
Time frame: From enrollment to the end of treatment at 3 months
OSDI is a standardized questionnaire for dry eye symptoms (Schiffman RM, et al. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. ). OSDI overall treatment effect (Month 1 and Month 3)
Symptom Assessment iN Dry Eye (SANDE) overall treatment effect
Time frame: From enrollment to the end of treatment at 3 months
SANDE is a validated short global dry eye symptom index (Schaumberg DA, et al. Development and validation of a short global dry eye symptom index. Ocul Surf. 2007 Jan;5(1):50-7) SANDE overall treatment effect (Month 1 and Month 3)
Fluorescein Break-up time (FBUT) overall treatment effect
Time frame: From enrollment to the end of treatment at 3 months
FBUT is a widely used method to assess tear film stability (Wolffsohn JS, et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. ) FBUT overall treatment effect (Month 1 and Month 3).
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 10 Dec 2024.
- Derived from this study: PubMed 40024993Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro(R) Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther. 2025 Apr;14(4):787-803. doi: 10.1007/s40123-025-01101-6. Epub 2025 Mar 1.
- Individual participant dataSharing planned: No
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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.
Edoardo Villani, MD study director
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HPMC+GlicoPro eyedrops and Hydroxypropyl-methylcellulose in people with Dry Eye, run by University of Milan at 1 site in Italy.
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 3 inclusion and 6 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ocular Surface Disease Index (OSDI) overall treatment effect (time frame: From enrollment to the end of treatment at 3 months). The study lists 3 primary outcomes in all. 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 NCT06726525, 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 10 Dec 2024.