Clinical Trials Logo
  1. Home
  2. Dry Eye
  3. NCT05825599

PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms

Dry Eye Clinical Trial

Official title:
An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "Hydroxypropyl Methylcellulose (HPMC)-Based Eyedrops" Used to Relieve Dry Eye Symptoms

Clinical Trial Summary

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface. Over the counter (OTC) artificial tears are typically the first line of dry eye treatment; they are meant to supplement the tears that cover the eye's surface. OTC products mimic the different layers of the tear film in order to maintain ocular hydration. Hydroxypropyl methylcellulose (HPMC or hypromellose) is a synthetic modification of the natural polymer, cellulose. It has been widely used in in ophthalmologic formulations such as eye drops and gels due to its solubility in water, biocompatibility, transparency and rheological properties. Eye drops containing HPMC are conventionally used to treat tear film disturbances including dry eye symptoms. 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 "Hydroxypropyl methylcellulose (HPMC)-based eyedrops" used as intended to relieve 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 "HPMC-based eyedrops" according to the Instructions for Use (IFU). "HPMC-based eyedrops" medical devices are ophthalmic solutions containing hydroxypropyl methylcellulose (HPMC) as key ingredient, a polymer able to relief eye discomfort thanks to its moisturizing, lubricating and muco-mimetic properties. HPMC can stabilize the tear film on the ocular surface by creating a protective, transparent and viscoelastic shield. 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), only one of the below reported "HPMC-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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05825599
Study type Interventional
Source C.O.C. Farmaceutici S.r.l.
Contact
Status Completed
Phase N/A
Start date September 6, 2022
Completion date January 30, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
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 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
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
Not yet recruiting NCT05965778 - Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome N/A
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
Completed NCT01718028 - The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects N/A