Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye

NCT06262100 | Completed

• 1 other identifier: EYL_23_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (1)

• Responder analysis

  28 days

Study Arms (1)

Carragelose

OTHER

Treatment with Carragelose containing eye drops

Device: Carragelose

Interventions

Carragelose DEVICE

Application of Carragelose containing eye drops

Carragelose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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;
• lissamine green conjunctival staining score ≥ 4 in the Oxford scale;
• Schirmer test score \< 2 mm;
• fluorescein TBUT = 0 seconds.
• 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 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.

Sponsors & Collaborators

• Marinomed Biotech AG: lead

Study Sites (1)

IOBA,Ocular Surface Research Group, University of Valladolid

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Margarita Calogne, PhD

  IOBA, University of Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 15, 2024
• Study Start: January 15, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)