Dry Eye SyndromesNCT06262100
Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye
A study testing Carragelose in people with Dry Eye Syndromes, run by Marinomed Biotech AG at 1 site in Spain.
Trial summary
Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Carragelose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 30 Jul 2024
- 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
- Adult patients (aged ≥ 18 years) from any sex or gender who provide written informed consent to participate.
- Diagnosis of DED by an ophthalmologist having DED-related symptoms lasting at least 3 months.
- Mild-to-moderate DED as defined above.
- Patients who do not use or can do without the use of contact lenses from at least 7 (±2) days before the Inclusion visit (Visit 2) and throughout the entire study period.
- Patients able to administer the study eye drops themselves in both eyes for the intended duration of the study (28 days).
- Patients willing not to use any other eye drops during the entire study period.
- Women with childbearing potential must commit to using effective methods of contraception during the entire study period and have a negative result on a pregnancy test at the Screening visit.
Who cannot join
- Patients with known hypersensitivity, allergy, or intolerance to the IP or any of its components.
- Patients with any ocular surface disease or condition other than DED.
- Patients with any other active ocular inflammatory disease or condition, glaucoma or who have received any ocular surgery during the last 6 months.
- Patients who have received lacrimal punctum occlusion during the previous month, or in whom it is planned during the study period.
- Patients with any of the following seriousness criteria:
- fluorescein corneal staining score ≥ 4 in the Oxford scale;
Show all 20Show fewer
- lissamine green conjunctival staining score ≥ 4 in the Oxford scale;
- Schirmer test score < 2 mm;
- fluorescein TBUT = 0 seconds.
- Patients receiving any other topical ocular medication, such as non-steroidal anti-inflammatory drugs, etc. within 30 days of inclusion (Visit 2).
- Patients with clinically relevant or uncontrolled systemic diseases (except for controlled Sjögren syndrome) during the last 3 months that may interfere with study assessments or results.
- Patients requiring or who have received topical ocular treatment with calcineurin inhibitors (such as cyclosporin or tacrolimus) during the last 12 weeks, corticosteroids during the last 4 weeks, blood derivatives (such as autologous/allogeneic serum, platelet-rich plasma, plasma rich in growth factors or umbilical cord-derived plasma), insulin or amniotic membrane preparations during the last week, during the last month before the Inclusion visit (Visit 2).
- Patients who have received treatment with any ocular lubricant after the Screening visit (Visit 1) other than the one specified in the protocol (Hydrabak).
- Patients who have started systemic treatments that may affect DED signs or symptoms, ocular surface or vision, during the last 3 months or if a change in the dose of such treatments is expected during the study.
- Inability to follow the study procedures, including attending all site visits, tests, and examinations.
- Mental incapacity that precludes adequate understanding or cooperation.
- Patients currently participating or who have participated in another investigational study during the last 30 days.
- Pregnant or breastfeeding women.
- Patients who, according to the investigator's criteria, are not suitable to participate in the study or comply with the study protocol.
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site
IOBA,Ocular Surface Research Group, University of Valladolid
Valladolid, 47011
About this study
Official title: Clinical Investigation to Evaluate the Lubricating Performance of Carragelose Containing Eye Drops in Patients Diagnosed with Mild-to-moderate Dry Eye Disease
Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed.
Read the detailed description
The objective is to evaluate the safety and performance of Carragelose®-containing eye drops in treating symptoms and signs of dry eye syndrom.
Patients will treat their eyes with one eye drop three times a day for 28 days. Baseline assessment will be performed after normal controlled environment and after adverse controlled environment. At the end of investigation ocular symptoms and ocular sign will be assessed after normal controlled environment and after adverse controlled environment. Differences between baseline and end of investigation will be evaluated for efficacy analysis.
- Conditions
- Dry Eye Syndromes
- Being tested
- Carragelose
- 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.
CarrageloseDevice
Application of Carragelose containing eye drops
| Study group | Role | What they receive |
|---|---|---|
| Carragelose | Other | Treatment with Carragelose containing eye drops Receives: Device: Carragelose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dry eye symptoms
Composite score on dry eye related ocular symptoms collected through numerical rating scales (NRS) for foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, and photophobia.
Measured: 28 days
Secondary outcomes (1)
Responder analysis
Patient responder rates evaluated as per the Numeric rating scale (0 to 10) scores.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Jan 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 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 Eye SyndromesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marinomed Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margarita Calogne, PhD, Principal investigator, IOBA, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262100
- Sponsor's protocol ID
- EYL_23_01
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco-Vazquez M, Calonge M, Dellago H, Unger-Manhart N, Savli M, Roch-Nakowitsch S, Prieschl-Grassauer E. Safety and Effectiveness of Iota-Carrageenan Eye Drops for the Treatment of Dry Eye Disease. Clin Ophthalmol. 2026 Jun 17;20:606363. doi: 10.2147/OPTH.S606363. eCollection 2026.
PubMed 42333311
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Lubricating Performance of Carragelose Containing Eye Drops in Patients Diagnosed with Mild-to-moderate Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06262100
- Acronym / sponsor ID
- EYL_23_01
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marinomed Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 15 Feb 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.
Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed.
Detailed description
The objective is to evaluate the safety and performance of Carragelose®-containing eye drops in treating symptoms and signs of dry eye syndrom.
Patients will treat their eyes with one eye drop three times a day for 28 days. Baseline assessment will be performed after normal controlled environment and after adverse controlled environment. At the end of investigation ocular symptoms and ocular sign will be assessed after normal controlled environment and after adverse controlled environment. Differences between baseline and end of investigation will be evaluated for efficacy analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carragelose | Other | Device: CarrageloseTreatment with Carragelose containing eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients (aged ≥ 18 years) from any sex or gender who provide written informed consent to participate.
- Diagnosis of DED by an ophthalmologist having DED-related symptoms lasting at least 3 months.
- Mild-to-moderate DED as defined above.
- Patients who do not use or can do without the use of contact lenses from at least 7 (±2) days before the Inclusion visit (Visit 2) and throughout the entire study period.
- Patients able to administer the study eye drops themselves in both eyes for the intended duration of the study (28 days).
Key exclusion criteria (20 listed)
- Patients with known hypersensitivity, allergy, or intolerance to the IP or any of its components.
- Patients with any ocular surface disease or condition other than DED.
- Patients with any other active ocular inflammatory disease or condition, glaucoma or who have received any ocular surgery during the last 6 months.
- Patients who have received lacrimal punctum occlusion during the previous month, or in whom it is planned during the study period.
- Patients with any of the following seriousness criteria:
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 |
|---|---|---|
| CarrageloseApplication of Carragelose containing eye drops | Device | Carragelose |
Primary outcome
Change in dry eye symptoms
Time frame: 28 days
Composite score on dry eye related ocular symptoms collected through numerical rating scales (NRS) for foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, and photophobia.
1 secondary outcome
Responder analysis
Time frame: 28 days
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 9 Dec 2024.
- Derived from this study: PubMed 42333311Blanco-Vazquez M, Calonge M, Dellago H, Unger-Manhart N, Savli M, Roch-Nakowitsch S, Prieschl-Grassauer E. Safety and Effectiveness of Iota-Carrageenan Eye Drops for the Treatment of Dry Eye Disease. Clin Ophthalmol. 2026 Jun 17;20:606363. doi: 10.2147/OPTH.S606363. eCollection 2026.
- 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.
Margarita Calogne, PhD principal investigator
IOBA, University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carragelose in people with Dry Eye Syndromes, run by Marinomed Biotech AG 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 7 inclusion and 20 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 9 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 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.
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 in dry eye symptoms (time frame: 28 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 NCT06262100, 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 9 Dec 2024.