Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190054
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-12-19
Brief Title:
Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease
Sponsor:
Fidia Farmaceutici spa
Organization:
Fidia Farmaceutici spa
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of an Eye Drops With Hydroxypropyl-methylcellulose and Inositol as Principal Components MERAMIRT in the Treatment of Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a profit multicentric prospective single-arm open-label non-pharmacological clinical investigation
Patients with diagnosis of moderate to severe dry eye disease with asthenopia and accommodative effort will receive MERAMIRT 1-2 drop per eye 3 times a day for 90 days
Patients with diagnosis of moderate to severe dry eye disease with asthenopia and accommodative effort will receive MERAMIRT 1-2 drop per eye 3 times a day for 90 days
Detailed Description:
MERAMIRT a class IIa medical device is indicated for hydration and lubrication of the ocular surface under conditions of eye disorders caused by environmental visual and mechanical stress also due to asthenopia and accommodation effort The main component of MERAMIRT are Hydroxypropyl-methylcellulose HPMC 03 and Inositol 01
HPMC has the property of moisturizing and lubricating the eye Inositol is used with an antioxidant role
Hypromellose is a polymer that has the property to tick and stabilize the tear film on the corneal surface which create a protective transparent and viscoelastic layer Inositol as other osmolytes may contribute to counteract the oxidant action on free radicals produced in condition of asthenopia and accommodative effort Such activity may indirectly support the muscular metabolic processes favoring the contractile response
MERAMIRT is a hydrating and lubricant tear replacement indicated in ocular isturbances caused by environmental visual and mechanic stress also due to asthenopia and accommodative effort
In a small open-label study a 03 hypromellose eye gel showed statistically significant effects in relieving ocular symptoms and in improving ocular comfort in patients with dry eye syndrome
Another recent study showed that treatment with punctual occlusion using hypromellose 2 was associated with a significant reduction in signs and symptoms in patients with dry eye
Based on the preliminary available background on the use of hypromellose in the management of dry eye syndrome this investigation has been designed to assess the efficacy and safety of a sterile ophthalmic solution that contains hypromellose and inositol MERAMIRT in a sample of VDT users suffering of moderate or severe DED with asthenopia and accommodative effort
HPMC has the property of moisturizing and lubricating the eye Inositol is used with an antioxidant role
Hypromellose is a polymer that has the property to tick and stabilize the tear film on the corneal surface which create a protective transparent and viscoelastic layer Inositol as other osmolytes may contribute to counteract the oxidant action on free radicals produced in condition of asthenopia and accommodative effort Such activity may indirectly support the muscular metabolic processes favoring the contractile response
MERAMIRT is a hydrating and lubricant tear replacement indicated in ocular isturbances caused by environmental visual and mechanic stress also due to asthenopia and accommodative effort
In a small open-label study a 03 hypromellose eye gel showed statistically significant effects in relieving ocular symptoms and in improving ocular comfort in patients with dry eye syndrome
Another recent study showed that treatment with punctual occlusion using hypromellose 2 was associated with a significant reduction in signs and symptoms in patients with dry eye
Based on the preliminary available background on the use of hypromellose in the management of dry eye syndrome this investigation has been designed to assess the efficacy and safety of a sterile ophthalmic solution that contains hypromellose and inositol MERAMIRT in a sample of VDT users suffering of moderate or severe DED with asthenopia and accommodative effort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None