Dry Eye DiseaseIDROFLOGNCT05724056
Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)
A study testing Idroflog® and Sodium Hyaluronate 0.18% (Vismed®) in people with Dry Eye Disease, run by Alfa Intes Industria Terapeutica Splendore s.r.l. at 5 sites in France.
Trial summary
This study aims at demonstrating the non-inferiority of Idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Idroflog® and Sodium Hyaluronate 0.18% (Vismed®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Mar 2023to 1 Dec 2023
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged ≥ 18 years
- Documented history of dry eyes and use of tear substitutes for at least 3 months within the last year
- Presence of corneal fluorescein staining (Oxford Scale, Score ≥ 2) in at least one eye
- Ocular Surface Disease Index (OSDI) ≥ 23
- Reduced tear break-up time (< 11 seconds)
Who cannot join
- Women who are pregnant or lactating
- Best far corrected visual acuity < 1/10 in both eyes
- Known hypersensitivity to one of the components of the study medications or test products
- Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period
- Ocular surgery (of any type, including laser surgery and punctal plugs) or ocular trauma within the 4 months prior to screening
- Active ocular infection
- Active allergies requiring treatment
- Glaucoma
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Amiens-Picardie
Amiens, 80054
Chau TRAN, Pr.
CHO Bordeaux - Site Pellegrin Centre François-Xavier Michelet, Service Ophtalmologie
Bordeaux, 33076
David TOUBOUL, Pr.
CHU Bicêtre, Service Ophtalmologie
Le Kremlin-Bicêtre, 94270
Marc LABETOULLE, Pr.
CHNO des 15-20
Paris, 75012
Christophe BAUDOUIN, Pr.
Hopital Fondation Adolphe de Rotschild
Paris, 75019
Serge DOAN, Pr.
About this study
Official title: Comparison of the Efficacy and Safety of Idroflog® (Sodium Hyaluronate and Hydrocortisone) and Sodium Hyaluronate for the Treatment of Dry Eye Disease
This study aims at demonstrating the non-inferiority of Idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months.
Read the detailed description
This is a randomized, controlled, multicenter, assessor-blinded, non-inferiority trial comparing Idroflog® (sodium hyaluronate and hydrocortisone) with sodium hyaluronate in participants with dry eye disease (DED).
DED is a common, multifactorial ocular condition, which affects between 5% and 35% of adults worldwide and significantly affects their quality of life. DED treatment is based on the management of contributing factors (local environment, elimination of harmful systemic and topical drugs), eyelid hygiene and the use of artificial tears. The gold standard of the latter is sodium hyaluronate solutions, which, however, lack any anit-inflammatory activity necessary for DED's management. In comparison to these, Idroflog containing both sodium hyaluronate and hydrocortisone in addition to the usual activities of sodium hyaluronate artificial tears (diluent, diffusive, protective, nutrient, lubricant) also provides steroidal anti-inflammatory activity. Therefore, this study aims at showing that Idroflog® performs as well as current standard of care (sodium hyaluronate artificial tears) in the treatment of moderate DED, while providing a potential benefit on the control of the sub-clinical inflammatory component of DED and maintaining the excellent safety profile of sodium hyaluronate artificial tears treatment.
- Conditions
- Dry Eye Disease
- Being tested
- Idroflog®, Sodium Hyaluronate 0.18% (Vismed®)
- Keywords
- Dry Eye, Idroflog, Ocular
- 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.
Idroflog®Device
Also called Study intervention
The study intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period.
Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above.
Sodium Hyaluronate 0.18% (Vismed®)Device
Also called Control intervention
The control intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period.
Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above.
| Study group | Role | What they receive |
|---|---|---|
| Idroflog® | Experimental | Patients randomized in this group will be treated with Sodium Hyaluronate 2 mg/ml and Hydrocortisone 10 μg/ml. Receives: Device: Idroflog® |
| Sodium Hyaluronate 0.18% (Vismed®) | Active comparator | Patients randomized in this group will be treated with Sodium Hyaluronate 0.18%. Receives: Device: Sodium Hyaluronate 0.18% (Vismed®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 30 days
Measured: 0 to 30 days of treatment
Secondary outcomes (7)
Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 60 days, and between inclusion and 90 days.
Measured: 0 to 60 and 90 days of treatment
Change in OSDI between inclusion and 30, 60 and 90 days.
Measured: 0 to 30, 60 and 90 days of treatment
Change in Tear Film Break Up Time between inclusion and 30, 60 and 90 days
Measured: 0 to 30, 60 and 90 days of treatment
Change in Pentascore score between inclusion and 30, 60 and 90 days
Measured: 0 to 30, 60 and 90 days of treatment
Changes in Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness) between inclusion and 30, 60 and 90 days
Measured: 0 to 30, 60 and 90 days of treatment
Safety 1: Changes in intraocular pressure between inclusion and 30, 60 and 90 days
Measured: 0 to 30, 60 and 90 days of treatment
Safety 2: Changes in visual acuity between inclusion and 90 days
Measured: 0 to 90 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Model description
- Participants will be enrolled equally and randomly into either treatment group: Idroflog® or Sodium Hyaluronate 0.18% (Vismed®). Once randomized, participants will receive the intervention for 90 days, and will be followed up at 30 days, 60 days, and 90 days.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfa Intes Industria Terapeutica Splendore s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc LABETOULLE, Pr., Principal investigator, CHU Bicêtre, Service Ophtalmologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724056
- Sponsor's protocol ID
- 2022-A01171-42
- Acronym
- IDROFLOG
- Status last verified
- Jan 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Results information from this trial will be submitted here to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers 10 years after the completion of the primary endpoint by contacting the principal investigator, and upon authorization by the Sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Idroflog® (Sodium Hyaluronate and Hydrocortisone) and Sodium Hyaluronate for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05724056
- Acronym / sponsor ID
- IDROFLOG / 2022-A01171-42
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye, Idroflog, Ocular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Alfa Intes Industria Terapeutica Splendore s.r.l.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Feb 2023 (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.
This study aims at demonstrating the non-inferiority of Idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months.
Detailed description
This is a randomized, controlled, multicenter, assessor-blinded, non-inferiority trial comparing Idroflog® (sodium hyaluronate and hydrocortisone) with sodium hyaluronate in participants with dry eye disease (DED).
DED is a common, multifactorial ocular condition, which affects between 5% and 35% of adults worldwide and significantly affects their quality of life. DED treatment is based on the management of contributing factors (local environment, elimination of harmful systemic and topical drugs), eyelid hygiene and the use of artificial tears. The gold standard of the latter is sodium hyaluronate solutions, which, however, lack any anit-inflammatory activity necessary for DED's management. In comparison to these, Idroflog containing both sodium hyaluronate and hydrocortisone in addition to the usual activities of sodium hyaluronate artificial tears (diluent, diffusive, protective, nutrient, lubricant) also provides steroidal anti-inflammatory activity. Therefore, this study aims at showing that Idroflog® performs as well as current standard of care (sodium hyaluronate artificial tears) in the treatment of moderate DED, while providing a potential benefit on the control of the sub-clinical inflammatory component of DED and maintaining the excellent safety profile of sodium hyaluronate artificial tears treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be enrolled equally and randomly into either treatment group: Idroflog® or Sodium Hyaluronate 0.18% (Vismed®). Once randomized, participants will receive the intervention for 90 days, and will be followed up at 30 days, 60 days, and 90 days.
| Arm | Type | Receives |
|---|---|---|
| Idroflog® | Experimental | Device: Idroflog®Patients randomized in this group will be treated with Sodium Hyaluronate 2 mg/ml and Hydrocortisone 10 μg/ml. |
| Sodium Hyaluronate 0.18% (Vismed®) | Active comparator | Device: Sodium Hyaluronate 0.18% (Vismed®)Patients randomized in this group will be treated with Sodium Hyaluronate 0.18%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged ≥ 18 years
- Documented history of dry eyes and use of tear substitutes for at least 3 months within the last year
- Presence of corneal fluorescein staining (Oxford Scale, Score ≥ 2) in at least one eye
Key exclusion criteria (8 listed)
- Women who are pregnant or lactating
- Best far corrected visual acuity < 1/10 in both eyes
- Known hypersensitivity to one of the components of the study medications or test products
- Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period
- Ocular surgery (of any type, including laser surgery and punctal plugs) or ocular trauma within the 4 months prior to screening
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 |
|---|---|---|
| Idroflog®Also: Study interventionThe study intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period. Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above. | Device | Idroflog® |
| Sodium Hyaluronate 0.18% (Vismed®)Also: Control interventionThe control intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period. Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above. | Device | Sodium Hyaluronate 0.18% (Vismed®) |
Primary outcome
Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 30 days
Time frame: 0 to 30 days of treatment
7 secondary outcomes
Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 60 days, and between inclusion and 90 days.
Time frame: 0 to 60 and 90 days of treatment
Change in OSDI between inclusion and 30, 60 and 90 days.
Time frame: 0 to 30, 60 and 90 days of treatment
Change in Tear Film Break Up Time between inclusion and 30, 60 and 90 days
Time frame: 0 to 30, 60 and 90 days of treatment
Change in Pentascore score between inclusion and 30, 60 and 90 days
Time frame: 0 to 30, 60 and 90 days of treatment
Changes in Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness) between inclusion and 30, 60 and 90 days
Time frame: 0 to 30, 60 and 90 days of treatment
Safety 1: Changes in intraocular pressure between inclusion and 30, 60 and 90 days
Time frame: 0 to 30, 60 and 90 days of treatment
Safety 2: Changes in visual acuity between inclusion and 90 days
Time frame: 0 to 90 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided. Results information from this trial will be submitted here to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers 10 years after the completion of the primary endpoint by contacting the principal investigator, and upon authorization by the Sponsor.
Related trials for Dry Eye Disease
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Marc LABETOULLE, Pr. principal investigator
CHU Bicêtre, Service Ophtalmologie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Idroflog® and Sodium Hyaluronate 0.18% (Vismed®) in people with Dry Eye Disease, run by Alfa Intes Industria Terapeutica Splendore s.r.l. at 5 sites in France.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessio DAVID, Mr. (+39 388 1109878, alessio.david@alfaintes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 30 days (time frame: 0 to 30 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2023.