Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05823961
Other study ID # COC-R5-CLHA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2022
Est. completion date July 28, 2023

Study information

Verified date May 2023
Source C.O.C. Farmaceutici S.r.l.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tear dysfunction, also known as Dry Eye Disease (DED) is frequently encountered in the clinical practice. It is a multifactorial disease of the ocular surface characterized by insufficient tear production, loss of homeostasis of the tear film, increased osmotic stress of the ocular surface, ocular discomfort and visual disturbance. Hyaluronic acid (HA) is a linear heteropolysaccharide (glycosaminoglycan) with unique hygroscopic, rheological, and lubricating properties. HA is naturally found at the human ocular surface where it contributes to the ocular hydration and lubrication thanks to its capability to bind water molecules.Sodium hyaluronate (SH), the salt form of HA, is widely used in artificial tears to counteract dry eye symptoms by facilitating eyelid sliding and reducing its friction on the corneal-conjunctival surface. Conventional HA-based eye drops contain linear HA. However, artificially cross-linked HA (CLHA) has several advantages over linear HA in alleviating dry eye symptoms. The increased viscoelasticity of CLHA results in a greater stability and a better resistance to the enzymatic degradation by hyaluronidase, while preserving all the properties of linear HA. Furthermore, chemical cross-linking of HA extends its permanence on the ocular surface, thus reducing the number of instillations and increasing patients' compliance. For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" used as intended to improve lacrimal abnormalities, even when associated with dry eye symptoms. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" according to the Instructions for Use (IFU). Each subject, after signing the Informed Consent Form (ICF), will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit (V0), one of the "CLHA-based eyedrops" products will be administered to the enrolled subject. The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 28, 2023
Est. primary completion date June 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient Informed consent form (ICF) signed; - Male and Female Aged = 18 years at the time of the signature of the ICF; - Patients with dry eye symptoms and/or redness, fatigue, discomfort of the eye or the ocular mucosa due to intrinsic or extrinsic factors such as atmospheric agents, environmental factors, inflammation, blepharitis, eye surgery, and/or use of contact lenses; - Willing not to use other eye drops during the entire treatment period. Exclusion Criteria: - Other - different - eyes clinical conditions (e.g. glaucoma); - Suspected alcohol or drug abuse; - Known hypersensitivity or allergy to Investigational Product (IP) components; - Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases, diabetes); - Participation in another investigational study; - Inability to follow all study procedures, including attending all site visits, tests and examinations; - Mental incapacity that precludes adequate understanding or cooperation.

Study Design


Intervention

Device:
Cross-linked hyaluronic acid eye drops
Cross-linked hyaluronic acid (CLHA)-based eyedrops

Locations

Country Name City State
Italy Azienda Ospedaliero-Universitaria Policlinico "G.Rodolico - San Marco" Catania CT

Sponsors (1)

Lead Sponsor Collaborator
C.O.C. Farmaceutici S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Schirmer Test I: to evaluate the performance of the "CLHA-based eyedrops" used to improve lacrimal abnormalities, even when associated with dry eye symptoms due to intrinsic or extrinsic factors, through the Schirmer I test From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Secondary Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "CLHA-based eyedrops" used to relieve discomfort to the eyes or ocular mucosa, and eye fatigue caused by intrinsic or extrinsic factors, through OSDI From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Secondary Change in Tear Break-up Time (TBUT): to evaluate the performance of the "CLHA-based eyedrops" used to improve tear film stability in subjects with dry eye symptoms and/or after eye surgery, through the TBUT test From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Secondary The global patient treatment tolerance to the "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" as assessed by the Visual Analogue Scale (VAS) as a difference between baseline and Day 30. Visual Analogue Scale:
Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
End of study visit (EOS/V2 = Day 30 ± 2)
Secondary To evaluate the patient satisfaction through a Rensis Likert 5 points patient satisfaction scale Rensis Likert 5 points patient satisfaction scale Minimum value: Very dissatisfied Maximum value: Very satisfied Higher scores mean a better outcome End of study visit (EOS/V2 = Day 30 ± 2)
See also
  Status Clinical Trial Phase
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT04081610 - Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Phase 1
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT03418727 - Dry Eye Disease Study With Brimonidine Phase 2
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Recruiting NCT04527887 - Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) Phase 4
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT04553432 - Dry Eye OmniLenz Application of Omnigen Research Study Phase 4
Recruiting NCT04109170 - Dry Eye Evaluation System Based on Bioinformatics
Completed NCT04105842 - Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type N/A
Completed NCT05505292 - Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Phase 4
Completed NCT04668131 - Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease N/A
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A