Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773963
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-02-22
Brief Title:
A Post-market Study to Evaluate the Effects of Sodium Hyaluronate Based Eye Drops in Patients Affected by Dry Eye Disease
Sponsor:
Montefarmaco OTC SpA
Organization:
Montefarmaco OTC SpA
Study Overview
Official Title:
A Post-market Study to Evaluate the Effects of Sodium Hyaluronate Based Eye Drops in Patients Affected by Dry Eye Disease
Status:
RECRUITING
Status Verified Date:
2023-03
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:
M-DED-2020
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 The reported prevalence of DED estimates vary widely from 5 to 33 which may reflect both differing populations and inconsistent diagnostic criteria Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain difficulty in performing daily activities and depression First-line therapy for treating dry eye consists of over the counter OTC artificial tear drops gels ointments or lubricants
Sodium hyaluronate commonly referred to as hyaluronic acid or HA is a naturally occurring polymer and is ubiquitous throughout the interstitial cellular space in humans It helps retain moisture in different types of tissue throughout the human body and aids lubrication between layers of tissue to eliminate friction - thus making it an ideal physiological tear film substitute
As a result of its coiled structure and large hydrophilic domains HA attracts and retains a large amount of water and therefore possesses the ability to retard water evaporation Following instillation HA-based solutions effectively moisturize the eye surface and prolong the beneficial wetting effect over time
Hyaluronic acid does not alter the normal surface of the eye like other types of tear substitutes It closely mimics the properties of a normal healthy tear film with a longer retention time on the corneal surface than a cellulose-based tear substitute
HA gels have also been used successfully in ophthalmic surgery for many years As a result of their unique physical and chemical properties HA solutions are similar to natural tears For that reason they are widely used in ophthalmology as lubricant eye drops for the treatment of sensations of ocular dryness
For these reasons an interventional confirmative post marketing clinical follow-up PMCF study was planned to evaluate the performance and safety of HA-based ophthalmic solutions ie Irilens Iridina Afomill Lubricating Eye Drops used to relieve dry eyes symptoms
The objectives of this 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 three investigational products IPs containing HA as key ingredient
The IPs are on the market with the following brand names
Irilens
Iridina
Afomill Lubricating Eye Drops
Primary
To evaluate the performance of IPs used as intended to relieve dry eye symptoms
Secondary
To evaluate the efficacy of IPs used as intended to relieve symptoms of DED
To evaluate the safety and tolerability of the IPs
To evaluate the patient satisfaction of the IPs
Sodium hyaluronate commonly referred to as hyaluronic acid or HA is a naturally occurring polymer and is ubiquitous throughout the interstitial cellular space in humans It helps retain moisture in different types of tissue throughout the human body and aids lubrication between layers of tissue to eliminate friction - thus making it an ideal physiological tear film substitute
As a result of its coiled structure and large hydrophilic domains HA attracts and retains a large amount of water and therefore possesses the ability to retard water evaporation Following instillation HA-based solutions effectively moisturize the eye surface and prolong the beneficial wetting effect over time
Hyaluronic acid does not alter the normal surface of the eye like other types of tear substitutes It closely mimics the properties of a normal healthy tear film with a longer retention time on the corneal surface than a cellulose-based tear substitute
HA gels have also been used successfully in ophthalmic surgery for many years As a result of their unique physical and chemical properties HA solutions are similar to natural tears For that reason they are widely used in ophthalmology as lubricant eye drops for the treatment of sensations of ocular dryness
For these reasons an interventional confirmative post marketing clinical follow-up PMCF study was planned to evaluate the performance and safety of HA-based ophthalmic solutions ie Irilens Iridina Afomill Lubricating Eye Drops used to relieve dry eyes symptoms
The objectives of this 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 three investigational products IPs containing HA as key ingredient
The IPs are on the market with the following brand names
Irilens
Iridina
Afomill Lubricating Eye Drops
Primary
To evaluate the performance of IPs used as intended to relieve dry eye symptoms
Secondary
To evaluate the efficacy of IPs used as intended to relieve symptoms of DED
To evaluate the safety and tolerability of the IPs
To evaluate the patient satisfaction of the IPs
Detailed Description:
Study Rationale 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 The reported prevalence of DED estimates vary widely from 5 to 33 which may reflect both differing populations and inconsistent diagnostic criteria Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain difficulty in performing daily activities and depression First-line therapy for treating dry eye consists of over the counter OTC artificial tear drops gels ointments or lubricants
Sodium hyaluronate commonly referred to as hyaluronic acid or HA is a naturally occurring polymer and is ubiquitous throughout the interstitial cellular space in humans It helps retain moisture in different types of tissue throughout the human body and aids lubrication between layers of tissue to eliminate friction - thus making it an ideal physiological tear film substitute
As a result of its coiled structure and large hydrophilic domains HA attracts and retains a large amount of water and therefore possesses the ability to retard water evaporation Following instillation HA-based solutions effectively moisturize the eye surface and prolong the beneficial wetting effect over time
Hyaluronic acid does not alter the normal surface of the eye like other types of tear substitutes It closely mimics the properties of a normal healthy tear film with a longer retention time on the corneal surface than a cellulose-based tear substitute
HA gels have also been used successfully in ophthalmic surgery for many years As a result of their unique physical and chemical properties HA solutions are similar to natural tears For that reason they are widely used in ophthalmology as lubricant eye drops for the treatment of sensations of ocular dryness
For these reasons an interventional confirmative post marketing clinical follow-up PMCF study was planned to evaluate the performance and safety of HA-based ophthalmic solutions ie Irilens Iridina Afomill Lubricating Eye Drops used to relieve dry eyes symptoms
Study Objective The objectives of this 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 three investigational products IPs containing HA as key ingredient
The IPs are on the market with the following brand names
Irilens
Iridina
Afomill Lubricating Eye Drops
Primary To evaluate the performance of IPs used as intended to relieve dry eye symptoms
Secondary
To evaluate the efficacy of IPs used as intended to relieve symptoms of DED
To evaluate the safety and tolerability of the IPs
To evaluate the patient satisfaction of the IPs
Methodology Potential candidates that according the investigator judgment could be treated with one of IPs will be identified with the assessment of their eligibility criteria 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 V0 as per clinical practice only one of the below reported IPs products can be assigned to the enrolled subject depending on investigator clinical evaluation and decision
Irilens
Iridina
Afomill Lubricating Eye Drops
The patient will perform 2 on site visits V0 and V2EOS To monitor the safety 1 phone contact is planned V1 to check for potential adverse events and concomitant medications intake
Data coming from additional assessments eg blood tests if done per clinical practice to perform DED diagnosis and evaluations might be collected and used
Number of subjects Planned About 90 patients in total Treatment duration After baseline visit and IP dispensing the treatment duration according to the Investigation Product IFU will be prolonged until the V2 EOS visit 25 5 days
Safety Analysis Set SAS The Safety Analysis Set SAS this set included all enrolled patients who took at least one dose of IP
Full Analysis Set FAS The Full Analysis Set FAS this set included all enrolled patients who took at least one dose of IP and with a baseline and at least one post-baseline performance assessment
Per protocol PP The Per-Protocol PP set would include all the FAS patients who a met all inclusionexclusion criteria liable to affect the performance assessment b did not present serious deviations of the protocol that may affect efficacy
I
IPs medical devices
Irilens with 04 HA as key ingredient
Iridina with 04 HA as key ingredient
Afomill Lubricating Eye Drops with 02 HA as key ingredient and distilled water of Chamomile
They are ophthalmic solutions with pH isotonicity and osmolarity compatible with eye tissue and tear fluid
Irilens Iridina and Afomill Lubricating Eye Drops are suitable in the treatment of dry eyes symptomatology due to use of contact lenses environmental reasons excessive hours of study or computer work Irilens and Iridina are suitable also after eye surgery
Dosedosage All IPs are available as 10 ml multi-dose bottles Irilens contains sodium chlorite as vanishing preservative Iridina is a preservative-free ophthalmic solution Afomill Lubricating Eye Drops contains Phmb 00002 as preservative
Irilens is also available as preservative-free 05 ml mono-dose vials The IP dosage for each individual case will be defined according to investigator judgment
Administration
The application of IP on eye surface should be performed in accordance to the indication for use
According to the Investigator judgement based on the subject clinical conditions and the indications reported on the IFU one of the investigational products can be assigned to the subject to be enrolled in the trial
The first administration and the intervals at which the treatment should be repeated to be done as per investigator judgment and according the IFU depend on various factors regarding the physiology of the patients eg type of eye-tear film anatomy age their lifestyle eg use of computer wearing of contact lenses
Primary efficacy endpoint
To evaluate the performance of IPs to relieve symptoms of dry eye the Shirmer I test ST might be completed at baseline V0 and end of study visit EOSV2 The evaluation will be performed stratified by study IPs
Secondary efficacy endpoints
To assess the efficacy of IPs used as intended to relieve symptoms of dry eye the difference of Ocular surface index OSDI Questionnaire between baseline V0 and end of study visit EOSV2 will be evaluated stratified by study IPs
To assess the efficacy of IPs used as intended to relieve symptoms of dry eye the Tear breakup time TBUT test might be completed at baseline V0 and end of study visit EOSV2 The evaluation will be performed stratified by study IPs
To evaluate the safety and tolerability of the IPs a Visual Analogue Scale VAS will be used
The patient satisfaction will be evaluated with a 5-points Likert Scale
Safety
Safety will be monitored through eye examination and adverse events including assessment of relationship to the IP
Time-points for efficacy and safety Baseline V0 and follow up visits performed
Statistical methods
Supposing a minimum difference of 20 equals to 1 mm of difference between after treatment and at baseline visit in terms of mean ST value with a standard deviation SD equal to 17 mm a correlation between baseline and end of treatment of 50 and a type I error of 5 25 patients are sufficient to reach a statistical power greater than 80 for each IPs
Moreover planning to enroll a total of 30 patients would allow for a 15 drop-out rate
Considering all IPs included 90 patients should be enrolled in the study In general all the variables will be descriptively analyzed by treatment groups and visit mean median standard deviation minimum and maximum for continuous variables after normality check of distribution with Kolmogorov-Smirnov test frequency distribution for categorical variables All the analysis will be detailed in the Statistical Analysis Plan SAP which will be finalized in Version 10 before the Data Base Lock DBL
In details the safety data will include at least physical examinations laboratory data and adverse events
Sodium hyaluronate commonly referred to as hyaluronic acid or HA is a naturally occurring polymer and is ubiquitous throughout the interstitial cellular space in humans It helps retain moisture in different types of tissue throughout the human body and aids lubrication between layers of tissue to eliminate friction - thus making it an ideal physiological tear film substitute
As a result of its coiled structure and large hydrophilic domains HA attracts and retains a large amount of water and therefore possesses the ability to retard water evaporation Following instillation HA-based solutions effectively moisturize the eye surface and prolong the beneficial wetting effect over time
Hyaluronic acid does not alter the normal surface of the eye like other types of tear substitutes It closely mimics the properties of a normal healthy tear film with a longer retention time on the corneal surface than a cellulose-based tear substitute
HA gels have also been used successfully in ophthalmic surgery for many years As a result of their unique physical and chemical properties HA solutions are similar to natural tears For that reason they are widely used in ophthalmology as lubricant eye drops for the treatment of sensations of ocular dryness
For these reasons an interventional confirmative post marketing clinical follow-up PMCF study was planned to evaluate the performance and safety of HA-based ophthalmic solutions ie Irilens Iridina Afomill Lubricating Eye Drops used to relieve dry eyes symptoms
Study Objective The objectives of this 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 three investigational products IPs containing HA as key ingredient
The IPs are on the market with the following brand names
Irilens
Iridina
Afomill Lubricating Eye Drops
Primary To evaluate the performance of IPs used as intended to relieve dry eye symptoms
Secondary
To evaluate the efficacy of IPs used as intended to relieve symptoms of DED
To evaluate the safety and tolerability of the IPs
To evaluate the patient satisfaction of the IPs
Methodology Potential candidates that according the investigator judgment could be treated with one of IPs will be identified with the assessment of their eligibility criteria 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 V0 as per clinical practice only one of the below reported IPs products can be assigned to the enrolled subject depending on investigator clinical evaluation and decision
Irilens
Iridina
Afomill Lubricating Eye Drops
The patient will perform 2 on site visits V0 and V2EOS To monitor the safety 1 phone contact is planned V1 to check for potential adverse events and concomitant medications intake
Data coming from additional assessments eg blood tests if done per clinical practice to perform DED diagnosis and evaluations might be collected and used
Number of subjects Planned About 90 patients in total Treatment duration After baseline visit and IP dispensing the treatment duration according to the Investigation Product IFU will be prolonged until the V2 EOS visit 25 5 days
Safety Analysis Set SAS The Safety Analysis Set SAS this set included all enrolled patients who took at least one dose of IP
Full Analysis Set FAS The Full Analysis Set FAS this set included all enrolled patients who took at least one dose of IP and with a baseline and at least one post-baseline performance assessment
Per protocol PP The Per-Protocol PP set would include all the FAS patients who a met all inclusionexclusion criteria liable to affect the performance assessment b did not present serious deviations of the protocol that may affect efficacy
I
IPs medical devices
Irilens with 04 HA as key ingredient
Iridina with 04 HA as key ingredient
Afomill Lubricating Eye Drops with 02 HA as key ingredient and distilled water of Chamomile
They are ophthalmic solutions with pH isotonicity and osmolarity compatible with eye tissue and tear fluid
Irilens Iridina and Afomill Lubricating Eye Drops are suitable in the treatment of dry eyes symptomatology due to use of contact lenses environmental reasons excessive hours of study or computer work Irilens and Iridina are suitable also after eye surgery
Dosedosage All IPs are available as 10 ml multi-dose bottles Irilens contains sodium chlorite as vanishing preservative Iridina is a preservative-free ophthalmic solution Afomill Lubricating Eye Drops contains Phmb 00002 as preservative
Irilens is also available as preservative-free 05 ml mono-dose vials The IP dosage for each individual case will be defined according to investigator judgment
Administration
The application of IP on eye surface should be performed in accordance to the indication for use
According to the Investigator judgement based on the subject clinical conditions and the indications reported on the IFU one of the investigational products can be assigned to the subject to be enrolled in the trial
The first administration and the intervals at which the treatment should be repeated to be done as per investigator judgment and according the IFU depend on various factors regarding the physiology of the patients eg type of eye-tear film anatomy age their lifestyle eg use of computer wearing of contact lenses
Primary efficacy endpoint
To evaluate the performance of IPs to relieve symptoms of dry eye the Shirmer I test ST might be completed at baseline V0 and end of study visit EOSV2 The evaluation will be performed stratified by study IPs
Secondary efficacy endpoints
To assess the efficacy of IPs used as intended to relieve symptoms of dry eye the difference of Ocular surface index OSDI Questionnaire between baseline V0 and end of study visit EOSV2 will be evaluated stratified by study IPs
To assess the efficacy of IPs used as intended to relieve symptoms of dry eye the Tear breakup time TBUT test might be completed at baseline V0 and end of study visit EOSV2 The evaluation will be performed stratified by study IPs
To evaluate the safety and tolerability of the IPs a Visual Analogue Scale VAS will be used
The patient satisfaction will be evaluated with a 5-points Likert Scale
Safety
Safety will be monitored through eye examination and adverse events including assessment of relationship to the IP
Time-points for efficacy and safety Baseline V0 and follow up visits performed
Statistical methods
Supposing a minimum difference of 20 equals to 1 mm of difference between after treatment and at baseline visit in terms of mean ST value with a standard deviation SD equal to 17 mm a correlation between baseline and end of treatment of 50 and a type I error of 5 25 patients are sufficient to reach a statistical power greater than 80 for each IPs
Moreover planning to enroll a total of 30 patients would allow for a 15 drop-out rate
Considering all IPs included 90 patients should be enrolled in the study In general all the variables will be descriptively analyzed by treatment groups and visit mean median standard deviation minimum and maximum for continuous variables after normality check of distribution with Kolmogorov-Smirnov test frequency distribution for categorical variables All the analysis will be detailed in the Statistical Analysis Plan SAP which will be finalized in Version 10 before the Data Base Lock DBL
In details the safety data will include at least physical examinations laboratory data and adverse events
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