Dry EyePhase 2/3NCT06517667
Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye
A Phase 2/3 study testing Icross tear substitute and Hyabak tear substitute in people with Dry Eye, run by University of Seville at 1 site in Spain.
Trial summary
The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed. 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?
- Icross tear substitute and Hyabak tear substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 1 Jun 2024
- Phase
- Phase 2/3
- 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
- Self-reported history DED.
- Ocular surface disease index (OSDI) > 13 points.
- Non-invasive tear film break-up time (NIBUT) < 10 s.
- Schirmer test (ST) without anesthesia ≥ 5 mm.
- MGD grade > 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG < 25%; MGD grade 2 = LAMG ≥ 25% and < 50%; MGD grade 3 = LAMG ≥ 50% and < 75%; MGD grade 4 = LAMG ≥ 75%).
Who cannot join
- Abnormal lid anatomy, including active blepharitis, and active lid margin.
- All corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
- Active ocular allergies.
- Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
- Intraocular surgery or laser ocular surgery within the previous 6 months.
- Use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
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- Systemic autoimmune diseases.
- Contact lens wearers.
- Pregnant or lactating women.
- Patients who did not understand or comprehend the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye: A Randomized, Single-Blind, Comparative Study
The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed.
- Conditions
- Dry Eye
- Being tested
- Icross tear substitute, Hyabak tear substitute
- 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.
Icross tear substituteDrug
Patients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid substitute into each eye 3 times per day for 3 months.
Hyabak tear substituteDrug
Patients were instructed to instill 1 drop of 0.15% hyaluronic acid substitute into each eye 3 times per day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Cross-linked hyaluronic acid | Experimental | Tear substitute based on 0.20% Cross-linked hyaluronic acid Receives: Drug: Icross tear substitute |
| Hyaluronic acid | Active comparator | Tear substitute based on 0.15% Cross-linked hyaluronic acid Receives: Drug: Hyabak tear substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid layer thickness (LLT)
The Lipiview® (Johnson \& JohsonVision Care, San Francisco, CA, USA) II ocular surface interferometer evaluates LLT automatically assesses LLT with nanometer precision by recording a 20 s video of the tear film interference pattern and then displays the data in interferometric color units (ICU), where1 ICU reflects approximately 1 nm of LLT.
Measured: This outcome measure was analyzed at baseline, 1 months and 3 months.
Secondary outcomes (3)
Ocular surface disease index questionnaire
The OSDI questionnaire were employed to assess the severity of DED symptoms, with scores ranging from 0 (indicating no ocular surface disease) to 100 (indicating severe ocular surface disease) points. This questionnaire was provided during consultations at each follow-up visit.
Measured: This outcome measure was analyzed at baseline, 1 months and 3 months.
Non-invasive tear film break-up time
Tear film stability was automatically assessed using NIBUT by projecting Placido rings from the Sirius device (CSO, Florence, Italy) onto the corneal surface. The time interval between the last blink and the initial distortion of the ring pattern was defined as first NIBUT. This variable was always measured at least 12 hours after administration of the study medication and the average of 3 consecutive measurements was calculated for statistical analysis.
Measured: This outcome measure was analyzed at baseline, 1 months and 3 months.
Schirmer I test without anesthesia
During the test, the patient is instructed to look upward while the test strip is carefully positioned between the palpebral conjunctiva of the lower eyelid and the bulbar conjunctiva. Subsequently, the patient is asked to keep their eyes gently closed for five minutes. After this period, the test strip is removed, and the Schirmer test score is determined by measuring the length of the moistened area on the strip.
Measured: This outcome measure was analyzed at baseline, 1 months and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Nov 2023
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid tear substitute or 0.15% hyaluronic acid A tear substitute into each eye 3 times per day for 3 months.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José-María Sánchez-González, University of Seville
- Investigators
- José-María Sánchez-González, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517667
- Sponsor's protocol ID
- CIVIUS-ABS-003
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.
PubMed 28777385Posarelli C, Passani A, Del Re M, Fogli S, Toro MD, Ferreras A, Figus M. Cross-Linked Hyaluronic Acid as Tear Film Substitute. J Ocul Pharmacol Ther. 2019 Sep;35(7):381-387. doi: 10.1089/jop.2018.0151. Epub 2019 Aug 2.
PubMed 31373862Ali S, Davinelli S, Mencucci R, Fusi F, Scuderi G, Costagliola C, Scapagnini G. Crosslinked Hyaluronic Acid with Liposomes and Crocin Confers Cytoprotection in an Experimental Model of Dry Eye. Molecules. 2021 Feb 6;26(4):849. doi: 10.3390/molecules26040849.
PubMed 33561944Guarise C, Acquasaliente L, Pasut G, Pavan M, Soato M, Garofolin G, Beninatto R, Giacomel E, Sartori E, Galesso D. The role of high molecular weight hyaluronic acid in mucoadhesion on an ocular surface model. J Mech Behav Biomed Mater. 2023 Jul;143:105908. doi: 10.1016/j.jmbbm.2023.105908. Epub 2023 May 15.
PubMed 37209594
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye: A Randomized, Single-Blind, Comparative Study
- ClinicalTrials.gov ID
- NCT06517667
- Acronym / sponsor ID
- CIVIUS-ABS-003
- Conditions
- Dry Eye
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 24 Jul 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 objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid tear substitute or 0.15% hyaluronic acid A tear substitute into each eye 3 times per day for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Cross-linked hyaluronic acid | Experimental | Drug: Icross tear substituteTear substitute based on 0.20% Cross-linked hyaluronic acid |
| Hyaluronic acid | Active comparator | Drug: Hyabak tear substituteTear substitute based on 0.15% Cross-linked hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported history DED.
- Ocular surface disease index (OSDI) > 13 points.
- Non-invasive tear film break-up time (NIBUT) < 10 s.
- Schirmer test (ST) without anesthesia ≥ 5 mm.
- MGD grade > 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG < 25%; MGD grade 2 = LAMG ≥ 25% and < 50%; MGD grade 3 = LAMG ≥ 50% and < 75%; MGD grade 4 = LAMG ≥ 75%).
Key exclusion criteria (10 listed)
- Abnormal lid anatomy, including active blepharitis, and active lid margin.
- All corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
- Active ocular allergies.
- Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
- Intraocular surgery or laser ocular surgery within the previous 6 months.
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 |
|---|---|---|
| Icross tear substitutePatients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid substitute into each eye 3 times per day for 3 months. | Drug | Cross-linked hyaluronic acid |
| Hyabak tear substitutePatients were instructed to instill 1 drop of 0.15% hyaluronic acid substitute into each eye 3 times per day for 3 months. | Drug | Hyaluronic acid |
Primary outcome
Lipid layer thickness (LLT)
Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.
The Lipiview® (Johnson \& JohsonVision Care, San Francisco, CA, USA) II ocular surface interferometer evaluates LLT automatically assesses LLT with nanometer precision by recording a 20 s video of the tear film interference pattern and then displays the data in interferometric color units (ICU), where1 ICU reflects approximately 1 nm of LLT.
3 secondary outcomes
Ocular surface disease index questionnaire
Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.
Non-invasive tear film break-up time
Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.
Schirmer I test without anesthesia
Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.
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 26 Jul 2024.
- Results publication: PubMed 28777385Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.
- Results publication: PubMed 31373862Posarelli C, Passani A, Del Re M, Fogli S, Toro MD, Ferreras A, Figus M. Cross-Linked Hyaluronic Acid as Tear Film Substitute. J Ocul Pharmacol Ther. 2019 Sep;35(7):381-387. doi: 10.1089/jop.2018.0151. Epub 2019 Aug 2.
- Results publication: PubMed 33561944Ali S, Davinelli S, Mencucci R, Fusi F, Scuderi G, Costagliola C, Scapagnini G. Crosslinked Hyaluronic Acid with Liposomes and Crocin Confers Cytoprotection in an Experimental Model of Dry Eye. Molecules. 2021 Feb 6;26(4):849. doi: 10.3390/molecules26040849.
- Results publication: PubMed 37209594Guarise C, Acquasaliente L, Pasut G, Pavan M, Soato M, Garofolin G, Beninatto R, Giacomel E, Sartori E, Galesso D. The role of high molecular weight hyaluronic acid in mucoadhesion on an ocular surface model. J Mech Behav Biomed Mater. 2023 Jul;143:105908. doi: 10.1016/j.jmbbm.2023.105908. Epub 2023 May 15.
- Individual participant dataSharing planned: Undecided
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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.
José-María Sánchez-González study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Icross tear substitute and Hyabak tear substitute in people with Dry Eye, run by University of Seville at 1 site in Spain.
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 5 inclusion and 10 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 26 Jul 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 Spain. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Lipid layer thickness (LLT) (time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.). 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 NCT06517667, which also lists 4 linked publications.
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 26 Jul 2024.