Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773976
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-02-22
Brief Title:
An Interventional Confirmative Post Marketing Clinical Followup PMCF Study to Evaluate Performance and Safety of Ophthalmic Solutions Used to Relieve Dry Eyes Like Symptoms in Glaucoma Patients
Sponsor:
Montefarmaco OTC SpA
Organization:
Montefarmaco OTC SpA
Study Overview
Official Title:
An Interventional Confirmative Post Marketing Clinical Followup PMCF Study to Evaluate Performance and Safety of Ophthalmic Solutions Used to Relieve Dry Eyes Like Symptoms in Glaucoma Patients
Status:
RECRUITING
Status Verified Date:
2023-10
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-GLAU-01-2020
Brief Summary:
Study Rationale The glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells These are central nervous system neurons that have their cell bodies in the inner retina and axons in the optic nerve
Degeneration of these nerves results in cupping a characteristic appearance of the optic disc and visual loss The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized Glaucoma affects more than 70 million people worldwide with approximately 10 being bilaterally blind making it the leading cause of irreversible blindness in the world Glaucoma can remain asymptomatic until it is severe resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it
The tear film is fundamental in the maintenance of the ocular surface Any condition that adversely affects the stability and function of the tear film such as dry eye symptom blepharitis and meibomian gland dysfunction dysfunctional tear film syndrome or toxicity of topical medications may result in onset of an ocular surface disease OSD The symptoms of OSD may include dryness burning or stinging itching irritation tearing photophobia foreign-body sensation grittiness redness fatigue fluctuating visual acuity and blurred vision
OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age OSD is seen in approximately 15 of the general elderly population and is reported in 48 to 59 of patients with medically treated glaucoma One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment
Ophthalmic solutions with soothing and refreshing proprieties as addon treatment to glaucoma therapy could relieve the OSD symptomatology dry eye like in glaucoma patients improving their quality of life
For these reasons an interventional confirmative post marketing clinical followup PMCF study was planned to evaluate the performance and safety of ophthalmic solutions used to relieve dry eyes like symptoms in glaucoma patients
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
The IPs are on the market with the following brand names
Afomill Refreshing Soothing
Afomill Anti-redness Eye Drops
Iridil
Degeneration of these nerves results in cupping a characteristic appearance of the optic disc and visual loss The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized Glaucoma affects more than 70 million people worldwide with approximately 10 being bilaterally blind making it the leading cause of irreversible blindness in the world Glaucoma can remain asymptomatic until it is severe resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it
The tear film is fundamental in the maintenance of the ocular surface Any condition that adversely affects the stability and function of the tear film such as dry eye symptom blepharitis and meibomian gland dysfunction dysfunctional tear film syndrome or toxicity of topical medications may result in onset of an ocular surface disease OSD The symptoms of OSD may include dryness burning or stinging itching irritation tearing photophobia foreign-body sensation grittiness redness fatigue fluctuating visual acuity and blurred vision
OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age OSD is seen in approximately 15 of the general elderly population and is reported in 48 to 59 of patients with medically treated glaucoma One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment
Ophthalmic solutions with soothing and refreshing proprieties as addon treatment to glaucoma therapy could relieve the OSD symptomatology dry eye like in glaucoma patients improving their quality of life
For these reasons an interventional confirmative post marketing clinical followup PMCF study was planned to evaluate the performance and safety of ophthalmic solutions used to relieve dry eyes like symptoms in glaucoma patients
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
The IPs are on the market with the following brand names
Afomill Refreshing Soothing
Afomill Anti-redness Eye Drops
Iridil
Detailed Description:
Study Rationale The glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells These are central nervous system neurons that have their cell bodies in the inner retina and axons in the optic nerve
Degeneration of these nerves results in cupping a characteristic appearance of the optic disc and visual loss The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized Glaucoma affects more than 70 million people worldwide with approximately 10 being bilaterally blind making it the leading cause of irreversible blindness in the world Glaucoma can remain asymptomatic until it is severe resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it
The tear film is fundamental in the maintenance of the ocular surface Any condition that adversely affects the stability and function of the tear film such as dry eye symptom blepharitis and meibomian gland dysfunction dysfunctional tear film syndrome or toxicity of topical medications may result in onset of an ocular surface disease OSD The symptoms of OSD may include dryness burning or stinging itching irritation tearing photophobia foreign-body sensation grittiness redness fatigue fluctuating visual acuity and blurred vision
OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age OSD is seen in approximately 15 of the general elderly population and is reported in 48 to 59 of patients with medically treated glaucoma One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment
Ophthalmic solutions with soothing and refreshing proprieties as addon treatment to glaucoma therapy could relieve the OSD symptomatology dry eye like in glaucoma patients improving their quality of life
For these reasons an interventional confirmative post marketing clinical followup PMCF study was planned to evaluate the performance and safety of ophthalmic solutions used to relieve dry eyes like symptoms in glaucoma patients
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
The IPs are on the market with the following brand names
Afomill Refreshing Soothing
Afomill Anti-redness Eye Drops
Iridil
Primary To evaluate the performance of IPs used as intended to relieve dry eye like symptoms in glaucoma patients
Secondary
To evaluate the performance of IPs used to affect the tear film in glaucoma patients
To evaluate the efficacy of IPs used as intended to relieve symptoms of OSD in glaucoma patients
To evaluate the maintenance of the basic condition of intraocular pressure in glaucoma patients
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 dispensed to the enrolled subject depending on investigator clinical evaluation and decision
Afomill Refreshing Soothing
Afomill Anti-redness Eye Drops
Iridil
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 glaucoma diagnosis and evaluations might be collected and used
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 30 5 days
The Safety Analysis Set SAS this set included all enrolled patients who took at least one dose of IP
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
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
Dosedosage All IPs are available as preservative-free 05 ml single-dose vials
Afomill Refreshing Soothing and Afomill Anti-redness Eye Drops are also available as preservative free 10 ml multi-dose bottle
Iridil is also available as 10 ml multi-dose bottle containing vanishing preservative sodium chlorite
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 The use of IP will be an add-on therapy to the glaucoma treatment prescribed as per clinical practice According to the Investigator judgement based on the subject clinical conditions and the indications reported on the IFU of IPs one of the investigational products can be dispensed 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 OSD dry eye like symptoms eg burning redness fatigue or irritation sensation according the IFU in glaucoma patients 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 evaluate the performance of IPs to affect the tear film in glaucoma patients 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 assess the efficacy of IPs used as intended to relieve symptoms of OSD dry eye like symptoms eg burning redness fatigue or irritation sensation according the IFU in glaucoma patients the difference of Ocular surface index OSDI Questionnaire between baseline V0 and end of study visit EOSV2 will be evaluated stratified by study IPs
The maintenance of the basic condition of glaucoma will be evaluated with Intraocular pressure IOP values
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 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 10 between after treatment and at baseline visit in terms of mean ST value with a standard deviation SD equal to 3 mm5 min a correlation between baseline and end of treatment of 80 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 dropout 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
Degeneration of these nerves results in cupping a characteristic appearance of the optic disc and visual loss The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized Glaucoma affects more than 70 million people worldwide with approximately 10 being bilaterally blind making it the leading cause of irreversible blindness in the world Glaucoma can remain asymptomatic until it is severe resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it
The tear film is fundamental in the maintenance of the ocular surface Any condition that adversely affects the stability and function of the tear film such as dry eye symptom blepharitis and meibomian gland dysfunction dysfunctional tear film syndrome or toxicity of topical medications may result in onset of an ocular surface disease OSD The symptoms of OSD may include dryness burning or stinging itching irritation tearing photophobia foreign-body sensation grittiness redness fatigue fluctuating visual acuity and blurred vision
OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age OSD is seen in approximately 15 of the general elderly population and is reported in 48 to 59 of patients with medically treated glaucoma One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment
Ophthalmic solutions with soothing and refreshing proprieties as addon treatment to glaucoma therapy could relieve the OSD symptomatology dry eye like in glaucoma patients improving their quality of life
For these reasons an interventional confirmative post marketing clinical followup PMCF study was planned to evaluate the performance and safety of ophthalmic solutions used to relieve dry eyes like symptoms in glaucoma patients
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
The IPs are on the market with the following brand names
Afomill Refreshing Soothing
Afomill Anti-redness Eye Drops
Iridil
Primary To evaluate the performance of IPs used as intended to relieve dry eye like symptoms in glaucoma patients
Secondary
To evaluate the performance of IPs used to affect the tear film in glaucoma patients
To evaluate the efficacy of IPs used as intended to relieve symptoms of OSD in glaucoma patients
To evaluate the maintenance of the basic condition of intraocular pressure in glaucoma patients
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 dispensed to the enrolled subject depending on investigator clinical evaluation and decision
Afomill Refreshing Soothing
Afomill Anti-redness Eye Drops
Iridil
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 glaucoma diagnosis and evaluations might be collected and used
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 30 5 days
The Safety Analysis Set SAS this set included all enrolled patients who took at least one dose of IP
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
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
Dosedosage All IPs are available as preservative-free 05 ml single-dose vials
Afomill Refreshing Soothing and Afomill Anti-redness Eye Drops are also available as preservative free 10 ml multi-dose bottle
Iridil is also available as 10 ml multi-dose bottle containing vanishing preservative sodium chlorite
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 The use of IP will be an add-on therapy to the glaucoma treatment prescribed as per clinical practice According to the Investigator judgement based on the subject clinical conditions and the indications reported on the IFU of IPs one of the investigational products can be dispensed 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 OSD dry eye like symptoms eg burning redness fatigue or irritation sensation according the IFU in glaucoma patients 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 evaluate the performance of IPs to affect the tear film in glaucoma patients 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 assess the efficacy of IPs used as intended to relieve symptoms of OSD dry eye like symptoms eg burning redness fatigue or irritation sensation according the IFU in glaucoma patients the difference of Ocular surface index OSDI Questionnaire between baseline V0 and end of study visit EOSV2 will be evaluated stratified by study IPs
The maintenance of the basic condition of glaucoma will be evaluated with Intraocular pressure IOP values
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 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 10 between after treatment and at baseline visit in terms of mean ST value with a standard deviation SD equal to 3 mm5 min a correlation between baseline and end of treatment of 80 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 dropout 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