PMCF Study to Evaluate Performance and Safety of "Xanoftal Next"

Sponsor

C.O.C. Farmaceutici S.r.l. (Industry)

Overall Status

Completed

CT.gov ID

NCT05829499

Collaborator

(none)

Enrollment

Location

Arm

2.2

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression.

Traditionally, dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases. However, recent literature has shown both conditions share similar characteristics, including several of their signs and symptoms (e.g. red, itchy, watery, and burning eyes).

On the other hand, red swollen eyelids, burning sensations, ocular irritation, loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis, an inflammatory disorder of eyelids affecting all the age and ethnic groups.

First-line therapy for treating dry eye symptoms consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration.

For these reasons, an interventional, non-comparative, Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Xanoftal Next" used to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome.

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 "Xanoftal Next" 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, the "Xanoftal Next" product 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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis Dry Eye Dry Eye Disease	Device: HPMC-HA eyedrops	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Interventional, Non-comparative, Single-center PMCF Study to Evaluate Performance and Safety of "Xanoftal Next" Used to Attenuate Symptoms of Seasonal Allergic Conjunctivitis, Even When Associated With Dry Eye Syndrome

Actual Study Start Date :

Dec 2, 2022

Actual Primary Completion Date :

Feb 6, 2023

Actual Study Completion Date :

Feb 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eyedrops treatment arm	Device: HPMC-HA eyedrops Ocular drops based upon HPMC and HA

Arm

Intervention/Treatment

Experimental: Eyedrops treatment arm

Device: HPMC-HA eyedrops

Ocular drops based upon HPMC and HA

Outcome Measures

Primary Outcome Measures

Change in Schirmer I test: to evaluate the performance of "Xanoftal Next" to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome, through the Schirmer I test [From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)]

Secondary Outcome Measures

Change in Tear Break-up Time (TBUT): to evaluate the performance of the "Xanoftal Next" to ensure relief from ophthalmic stress, through the TBUT test [From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)]
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "Xanoftal Next" to reduce dry eye symptoms, mild to moderate, accompanied by itching, burning, foreign body sensation, redness due intrinsic or extrinsic causes [From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)]
To evaluate the safety and tolerability of the "Xanoftal Next" through Visual Analogue Scale (VAS) - evaluation of symptoms related to dry eye disease (burning, fatigue, discomfort, redness) [End of study visit (EOS/V2 = Day 30 ± 2)]
To evaluate the patient satisfaction through a 5-points Likert Scale [End of study visit (EOS/V2 = Day 30 ± 2)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed patient Informed consent form (ICF);
Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
Patients with ophthalmic discomfort due eye allergy or other eye discomfort caused by environmental or mechanical stress (e.g. use of computer and/or smartphone), including contact lenses wearing and blepharitis;
Willing not to use other eye drops during the entire treatment period.

Exclusion Criteria:

Other - different - eyes clinical conditions (e.g. glaucoma);
Known hypersensitivity or allergy to Investigational Product (IP) components;
Suspected alcohol or drug abuse;
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.