Clinical Trials Logo
  1. Home
  2. Dry Eye
  3. NCT05824000

PMCF Study to Evaluate Performance and Safety of "Optrex Double Action Soothing and Lubricating Drops"

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 "Optrex Double Action Soothing and Lubricating Drops"

Clinical Trial Summary

Allergic conjunctivitis (or ocular allergy) and dry eye disease (DED) are two major ocular surface disorders affecting millions of people. A typical clinical symptom of allergic conjunctivitis is itching which is also observed in subjects suffering from DED. Common symptoms of DED also include a foreign body sensation, dryness, irritation, burning sensation and visual disturbance. Patients with allergic conjunctivitis or moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression. Gel-based artificial tear supplements may offer longer retention times and act as a supplement to the mucin layer. Carbomer (also known as Carbopol polymers) is awater-soluble polymeric resin that exhibit excellent viscoelastic and mucoadhesive properties when compared with other polymers. Carbomer is used in liquid or semisolid pharmaceutical, cosmetics, and ophthalmic formulations as rheology modifiers. Aqueous carbomer gels have been used for the treatment of dry eye and allergic conjunctivitis as they provide prolonged ocular residence time of conventional ophthalmic solutions. Furthermore, carbomer has shown compatibility with many active ingredients, good thermal stability, excellent organoleptic characteristics, and good patient acceptance. 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 "Optrex Double Action soothing and lubricating drops" for itchy and watery eyes. 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 the use of "Optrex Double Action soothing and lubricating drops" according to the Instructions for Use (IFU). Each subject, after signing the Informed Consent Form, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit, "Optrex Double Action soothing and lubricating drops" will be prescribed 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 NCT05824000
Study type Interventional
Source C.O.C. Farmaceutici S.r.l.
Contact
Status Completed
Phase N/A
Start date June 7, 2022
Completion date August 5, 2022
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 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
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A