Dry Eye Syndromes
Conditions
Keywords
ocular surface discomfort
Brief summary
The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections. The main questions it aims to answer are: * can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs? * can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision? Each participant will be randomized into each of two arms: 1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day; 2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day; The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement. In any case, the instillation of saline solution should not alter the ocular surface.
Interventions
DEVICEThealoz Duo;
THEALOZ DUO is a solution containing trehalose (3%), sodium hyaluronate (0.15%), sodium chloride, trometamol, hydrochloric acid, and water for injections; Hydraback is a solution containing a sodium chloride 0.9 %, sodium dihydrogen phosphate dihydrate, sodium phosphate dodecahydrate, water for preparations for injection.
DEVICEsham (Hydrabak)
Hydrabak is an ophthalmic solution containing: sodium chloride 0.9%, sodium dihydrogen phosphate dihydrate, sodium phosphate dodecahydrate, and water for injectable preparations
Sponsors
Francesco Bandello
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
There are two teams: 1. MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks: * dispensation to the patient the Investigational medical device (Thealoz Duo) or saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate); * accountability of Investigational medical device and saline solution; * verify the compliance and therapeutic adherence of the patient; * discussion with the patient regarding the respect of the masked condition of the study; 2. UNMASKED TEAMS: * informed consent process; * to perform the follow-up visit and assessments provided to test the ocular surface.
Intervention model description
The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient with retinal disease who required anti-VEGF therapy via intravitreal injections; * patient who has already received at least 2 anti-VEGF therapy via intravitreal injections in the study eye during the last 6 months before the baseline; * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
* patient with naive retinal disease who has already received \< 2 anti-VEGF therapy via intravitreal injections in the study eye; * subjects with autoimmune pathologies involving the ocular surface (e.g.Sjögren's syndrome), dry eye syndrome, eyelid disease that can induce changes in ocular surface (e.g. entropion, ectropion, lagophthalmos, trichiasis, ptosis), with any other systemic disease that may confound the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Administration of Ocular Surface Disease Index (OSDI) to the patient | 3 months and 1 week | The primary outcome is to evaluate the improvement of the dry-eye signs and changes in the ocular surface in patients who have received the intravitreal injections through the administration of Ocular Surface Disease Index (OSDI) at baseline, at month 1 and month 3 after the intravitreal injections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of matrix metalloproteinase 9 gene expression | 3 months and 1 week | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -evaluation of matrix metalloproteinase 9 gene expression. |
| TearLab Osmolarity | 3 months and 1 week | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -TearLab Osmolarity. |
| Schirmer's test | 3 months and 1 week | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -Schirmer's test. |
| administration of Visual Analog Scale for Pain to the patient | 3 months and 1 week | The Visual Analogue Scale measures pain intensity and consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be'). |
| conjunctival hyperemia according to Efron grading scale | 3 months and 1 week | The Efron grading scale describe the severity of contact lens complications (grade 0: normal; grade 1: trace; grade 2: mild; grade 3: moderate; grade 4: severe). |
| fluorescein staining | 3 months and 1 week | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -fluorescein staining. |
| tear film Break Up Time (tBUT) | 3 months and 1 week | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -tear film Break Up Time (tBUT). |
Countries
Italy
Contacts
Primary ContactEmanuela Aragona, MD-PhD
Outcome results
None listed