Dry EyeNCT06159569
Performance and Tolerability of the Medical Device LACRIACT
A study testing LACRIACT in people with Dry Eye and Contact Lens Acute Red Eye, run by Laboratórios Baldacci S.A at 1 site in Italy.
Trial summary
The goal of this study is testing LACRIACT® eye drops, a medical device, to see how well it works and if people can use it safely. The Investigators will study this in people who have dry eyes, some of whom wear contact lenses, and some who do not. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye, Contact Lens Acute Red Eye, Photophobia
- What is being tested?
- LACRIACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2021to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders aged 18-75;
- Patients with clinically diagnosed mild to moderate dry eye syndrome based on Ocular Surface Disesae Index OSDI questionnaire (Italian version) and medical examination;
- Patients with at least two signs and/or symptoms of ocular discomfort;
- Patients with good eyelid mobility;
- Patients must be able to attend the visits scheduled in the study protocol and to follow the instructions given by the Investigator;
- Patients must be able to fill in their diary at home;
- Patients who have given their written informed consent.
Who cannot join
- Ocular hypertension (>21 mmHg) or glaucoma with/without alterations of the field of vision;
- Presence of any other eye acute conditions different from eye dry (e.g. acute ulcerative keratitis; acute purulent ophthalmia; ocular tuberculosis; ocular mycosis);
- Eye inflammation or acute eye infection within 3 months before the enrolment;
- Eye surgery within 1 year before enrolment or LASIK at any time before enrolment;
- Known hypersensitivity to any of the components of the devices used in this study;
- Concomitant use of any other eye drop;
Show all 13Show fewer
- Concomitant use of any local or systemic treatment for dry eye;
- Concomitant use of products with known corneal toxicity and/or steroids, NSAID, or anti-glaucoma drugs;
- Concomitant hormonal therapy;
- Concomitant autoimmune inflammatory diseases or diabetes mellitus;
- Current or past participation in any other clinical trial which has ended less than a month before the enrolment;
- Use of hard contact lenses;
- Patients unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
Trial locations and contacts
1 site in 1 country.
Italy1 site
USOD Oculistica, Presidio Ospedaliero di Crotone, Ospedale San Giovanni di Dio
Crotone, 88900
About this study
Official title: Open Not Comparative Clinical Trial on the Performance and Tolerability of the Medical Device LACRIACT, Eye Drops for the Treatment of Dry Eye
The goal of this study is testing LACRIACT® eye drops, a medical device, to see how well it works and if people can use it safely. The Investigators will study this in people who have dry eyes, some of whom wear contact lenses, and some who do not. To obtain data from 20 participants, the investigators will first screen 22 patients, as two of them may not meet the requirements. If someone quits the study, the Investigators will not replace them with someone else.
A person can partecipate in the study if they meet certain criteria in the study plan, complete the entire treatment, and use eye drops correctly at least 80% of the time. The Investigators running the study might also include up to 10 people who wear soft contact lenses out of the 20 in total.
This study will be conducted at a clinic in Italy.
Read the detailed description
Dry eye disease is defined as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and subacute inflammation of the ocular surface (Ocul Surf. 2007;5(2):75). Tear hyperosmolarity is responsible for several morphological changes in conjunctival and corneal cells, and stimulation of the inflammatory cascade, resulting in the release of mediators such as cytokines and proteolytic enzymes, loss of both mucin-producing goblet cells and corneal barrier function. The international literature shows that ophthalmic products containing the biologic glycosaminoglycan sodium hyaluronate (HA) at concentrations around 0.2% (between 0.15% and 0.25%) are well tolerated and no safety problems have been reported. In fact, being hydrophilic, HA binds a large amount of water and forms a viscous hydrated gel even at low concentrations, which helps to restore and stabilize the compromised tear film in dry eye patients. Recently, the use of osmoprotectants, which are able to counteract the hyperosmolarity of the tear film, has been evaluated as a beneficial strategy for the treatment of dry eye. Osmoprotection can be considered as a natural response of biological structures that, through the accumulation of small biological molecules on cell surfaces, causes an adaptation of these structures to a hyperosmotic environment. For this reason, the selection of new osmoprotective agents for the treatment of dry eye should be a goal of current clinical research in ophthalmology. LABORATORI BALDACCI has recently selected 5-oxo-2-pyrrolidinecarboxylic acid (PCA), known as pyroglutamic acid, an endogenous molecule able to meet the expectations of demonstrating beneficial behavior in reducing dry eye symptoms. The medical literature (Tampucci S et al, Pharmaceutics. 2018), demonstrated that the scarce tear volume in contact with the corneal epithelial cells in atropine-induced dry eye in rabbits was influenced by the presence of hydrophilic PCA, which was able to provide protection against desiccation due to its osmoprotective activity and high water-binding capacity, thereby maintaining a significant tear volume in the conjunctival sac. Furthermore, the combination of PCA and HA allows for a significant improvement in this behavior, probably due to the ability of HA to hold approximately 1000 times its weight in water with respect to the surrounding tissue. These positive preclinical results should be confirmed in the ongoing clinical trials. The combination of PCA as an osmoprotective agent and HA as a pharmaceutical mucoadhesive and viscosifying agent capable of optimizing the ocular pharmacokinetic behavior of PCA may be a promising combination for the treatment of dry eye.
LACRIACT®, the medical device ophthalmic solution used in this clinical trial, was designed to act locally without the need for systemic absorption. In fact, PCA and HA are physiological substances that do not present toxicity issues. LACRIACT® was formulated to alleviate dry eye symptoms through localized physical action, without involvement of any immunological or pharmacological activity, and minimizing discomfort upon application.
This open, non-randomized trial will take place at an Italian clinical site. The purpose is to assess the performance, safety, and tolerability of LACRIACT® eye drops in patients with mild to moderate dry eye syndrome, with or without contact lenses. The investigators opted to treat solely mild to moderate dry eye because severe forms of dry eye necessitate a comprehensive approach where tear substitutes constitute only a part of the therapy. Assessing the efficacy and tolerance of LACRIACT becomes more complex when used with concomitant local and systemic dry eye treatments. The sample size has been determined to be 20 evaluable patients, and the Investigators plan to screen 22 patients to achieve this number (allowing for 2 screening failures). Dropouts will not be replaced. The Investigator may include a maximum of 10 patients (out of a total of 20) who regularly wear soft contact lenses, but this is optional.
- Conditions
- Dry Eye, Contact Lens Acute Red Eye, Photophobia, Discomfort
- Being tested
- LACRIACT
- Keywords
- LACRIACT, Contact lens, Photophobia, Stickiness of eyelashes, Italy
- Medical subject headings
- Dry Eye Syndromes, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACRIACTDevice
LACRIACT is is a preservative free ophthalmic sterile medical device solution. The solution is packaged in closable vials of inert material that does not affect the contents (clear low-density polyethylene), each vial contains 0.5 ml of solution.
Eligible patients will start the treatment. Patients will receive the box of eye drops, and will be instructed on how to self-administer 1 drop in each eye 4 times a day for 30 days starting from the day following the visit.
| Study group | Role | What they receive |
|---|---|---|
| Population treated with LACRIACT | Experimental | 20 patients affected by dry eye who met the inclusion and exclusion criteria.. It is optional for the Investigator to recruit a sub-group of patients (maximum number 10 of 20 recruited patients) with regular soft contact lens that will be analysed separately. Receives: Device: LACRIACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer Test
The test will be performed as follows:
A standardized tear testing strips is placed between the eyeball and the lateral margin of the lower lid, the conjunctival sac of the patient, and the advancement of a tear film over a period of 5 minutes is noted. The Investigator traces the tear edge with a pen, measuring the shortest and longest parts. More than 10 mm of moisture on the filter paper after 5 minutes is a sign of normal tear production.
Both eyes are tested at the same time and both eyes normally release the same amount of tears.
The values obtained after 30 days of treatment will be compared with the baseline (day 0) values.
Measured: 30 days
Serious Adverse Device Effects (SADE), Serious Adverse Events (SAE), Adverse Device Effects (ADE), Adverse Events (AE) and Device Deficiency (DD)
The occurrence of SADE, SAE, ADE, AE and DD will be monitored to assess the overall safety of the device
Measured: 30 days
Secondary outcomes (21)
Tear breakup time (TBUT))
The test will be performed as follows:
The fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. A TBUT under 10 seconds is considered abnormal.
The TBUT is able to confirm the result of the performed Schirmer test. The TBUT values obtained after 30 days of treatment will be compared with the baseline (day 0) values.
Measured: 30 days
Foreign body sensation
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Redness
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Lachrymation
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Photophobia
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Discomfort
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Mucus hypersecretion
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Swelling
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Pain/soreness
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Stinging
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Burning
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Itching
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Blurred vision
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Stickiness of eyelashes
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Vision changes
The symptom will be measured using the following 4-point verbal rating scale: 0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms.
The symptom will be collected by the patient at the time of eye drop administration and 10 minutes thereafter during the final visit (day 30)
Measured: 30 days
Discomfort on lens insertion
In the contact lenses wearer patients only this parameter will be evaluated (using a 4-point Verbal Rating Scale (0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms)
Measured: 30 days
Discomfort on lens removal
In the contact lenses wearer patients only this parameter will be evaluated (using a 4-point Verbal Rating Scale (0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms)
Measured: 30 days
Dryness on lens insertion
In the contact lenses wearer patients only this parameter will be evaluated (using a 4-point Verbal Rating Scale (0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms)
Measured: 30 days
Dryness on lens removal
In the contact lenses wearer patients only this parameter will be evaluated (using a 4-point Verbal Rating Scale (0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms)
Measured: 30 days
Stinging at 1st and 2nd hour after lens insertion
In the contact lenses wearer patients only this parameter will be evaluated (using a 4-point Verbal Rating Scale (0 = no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms)
Measured: 30 days
Patient General satisfaction
This parameter will be recorded by the patients using a 4-point Verbal Rating Scale (1= poor satisfaction, 2= moderate satisfaction; 3= good satisfaction; 4= very good satisfaction) and reported in the final visit (day 30).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start9 Sep 2021
- Primary completion18 Dec 2022
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open, non comparative study with a medical device
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratórios Baldacci S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Gennaro Crugliano, MD, Prof, Principal investigator, Ospedale San Giovanni di Dio, Crotone (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159569
- Sponsor's protocol ID
- LACRIACT 1/2020
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
PubMed 17508116Ang BCH, Sng JJ, Wang PXH, Htoon HM, Tong LHT. Sodium Hyaluronate in the Treatment of Dry Eye Syndrome: A Systematic Review and Meta-Analysis. Sci Rep. 2017 Aug 21;7(1):9013. doi: 10.1038/s41598-017-08534-5.
PubMed 28827614Fraser JR, Laurent TC, Laurent UB. Hyaluronan: its nature, distribution, functions and turnover. J Intern Med. 1997 Jul;242(1):27-33. doi: 10.1046/j.1365-2796.1997.00170.x.
PubMed 9260563Tampucci S, Monti D, Burgalassi S, Terreni E, Zucchetti E, Baldacci F, Chetoni P. Effect of 5-Oxo-2-Pyrrolidinecarboxylic Acid (PCA) as a New Topically Applied Agent for Dry Eye Syndrome Treatment. Pharmaceutics. 2018 Aug 25;10(3):137. doi: 10.3390/pharmaceutics10030137.
PubMed 30149648
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Not Comparative Clinical Trial on the Performance and Tolerability of the Medical Device LACRIACT, Eye Drops for the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT06159569
- Acronym / sponsor ID
- LACRIACT 1/2020
- Conditions
- Dry Eye, Contact Lens Acute Red Eye, Photophobia, Discomfort
- Keywords
- LACRIACT, Contact lens, Photophobia, Stickiness of eyelashes, Italy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laboratórios Baldacci S.AIndustry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is testing LACRIACT® eye drops, a medical device, to see how well it works and if people can use it safely. The Investigators will study this in people who have dry eyes, some of whom wear contact lenses, and some who do not. To obtain data from 20 participants, the investigators will first screen 22 patients, as two of them may not meet the requirements. If someone quits the study, the Investigators will not replace them with someone else.
A person can partecipate in the study if they meet certain criteria in the study plan, complete the entire treatment, and use eye drops correctly at least 80% of the time. The Investigators running the study might also include up to 10 people who wear soft contact lenses out of the 20 in total.
This study will be conducted at a clinic in Italy.
Detailed description
Dry eye disease is defined as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and subacute inflammation of the ocular surface (Ocul Surf. 2007;5(2):75). Tear hyperosmolarity is responsible for several morphological changes in conjunctival and corneal cells, and stimulation of the inflammatory cascade, resulting in the release of mediators such as cytokines and proteolytic enzymes, loss of both mucin-producing goblet cells and corneal barrier function. The international literature shows that ophthalmic products containing the biologic glycosaminoglycan sodium hyaluronate (HA) at concentrations around 0.2% (between 0.15% and 0.25%) are well tolerated and no safety problems have been reported. In fact, being hydrophilic, HA binds a large amount of water and forms a viscous hydrated gel even at low concentrations, which helps to restore and stabilize the compromised tear film in dry eye patients. Recently, the use of osmoprotectants, which are able to counteract the hyperosmolarity of the tear film, has been evaluated as a beneficial strategy for the treatment of dry eye. Osmoprotection can be considered as a natural response of biological structures that, through the accumulation of small biological molecules on cell surfaces, causes an adaptation of these structures to a hyperosmotic environment. For this reason, the selection of new osmoprotective agents for the treatment of dry eye should be a goal of current clinical research in ophthalmology. LABORATORI BALDACCI has recently selected 5-oxo-2-pyrrolidinecarboxylic acid (PCA), known as pyroglutamic acid, an endogenous molecule able to meet the expectations of demonstrating beneficial behavior in reducing dry eye symptoms. The medical literature (Tampucci S et al, Pharmaceutics. 2018), demonstrated that the scarce tear volume in contact with the corneal epithelial cells in atropine-induced dry eye in rabbits was influenced by the presence of hydrophilic PCA, which was able to provide protection against desiccation due to its osmoprotective activity and high water-binding capacity, thereby maintaining a significant tear volume in the conjunctival sac. Furthermore, the combination of PCA and HA allows for a significant improvement in this behavior, probably due to the ability of HA to hold approximately 1000 times its weight in water with respect to the surrounding tissue. These positive preclinical results should be confirmed in the ongoing clinical trials. The combination of PCA as an osmoprotective agent and HA as a pharmaceutical mucoadhesive and viscosifying agent capable of optimizing the ocular pharmacokinetic behavior of PCA may be a promising combination for the treatment of dry eye.
LACRIACT®, the medical device ophthalmic solution used in this clinical trial, was designed to act locally without the need for systemic absorption. In fact, PCA and HA are physiological substances that do not present toxicity issues. LACRIACT® was formulated to alleviate dry eye symptoms through localized physical action, without involvement of any immunological or pharmacological activity, and minimizing discomfort upon application.
This open, non-randomized trial will take place at an Italian clinical site. The purpose is to assess the performance, safety, and tolerability of LACRIACT® eye drops in patients with mild to moderate dry eye syndrome, with or without contact lenses. The investigators opted to treat solely mild to moderate dry eye because severe forms of dry eye necessitate a comprehensive approach where tear substitutes constitute only a part of the therapy. Assessing the efficacy and tolerance of LACRIACT becomes more complex when used with concomitant local and systemic dry eye treatments. The sample size has been determined to be 20 evaluable patients, and the Investigators plan to screen 22 patients to achieve this number (allowing for 2 screening failures). Dropouts will not be replaced. The Investigator may include a maximum of 10 patients (out of a total of 20) who regularly wear soft contact lenses, but this is optional.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open, non comparative study with a medical device
| Arm | Type | Receives |
|---|---|---|
| Population treated with LACRIACT | Experimental | Device: LACRIACT20 patients affected by dry eye who met the inclusion and exclusion criteria.. It is optional for the Investigator to recruit a sub-group of patients (maximum number 10 of 20 recruited patients) with regular soft contact lens that will be analysed separately. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both genders aged 18-75;
- Patients with clinically diagnosed mild to moderate dry eye syndrome based on Ocular Surface Disesae Index OSDI questionnaire (Italian version) and medical examination;
- Patients with at least two signs and/or symptoms of ocular discomfort;
- Patients with good eyelid mobility;
- Patients must be able to attend the visits scheduled in the study protocol and to follow the instructions given by the Investigator;
Key exclusion criteria (13 listed)
- Ocular hypertension (>21 mmHg) or glaucoma with/without alterations of the field of vision;
- Presence of any other eye acute conditions different from eye dry (e.g. acute ulcerative keratitis; acute purulent ophthalmia; ocular tuberculosis; ocular mycosis);
- Eye inflammation or acute eye infection within 3 months before the enrolment;
- Eye surgery within 1 year before enrolment or LASIK at any time before enrolment;
- Known hypersensitivity to any of the components of the devices used in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LACRIACTLACRIACT is is a preservative free ophthalmic sterile medical device solution. The solution is packaged in closable vials of inert material that does not affect the contents (clear low-density polyethylene), each vial contains 0.5 ml of solution. Eligible patients will start the treatment. Patients will receive the box of eye drops, and will be instructed on how to self-administer 1 drop in each eye 4 times a day for 30 days starting from the day following the visit. | Device | Population treated with LACRIACT |
Primary outcome
Schirmer Test
Time frame: 30 days
The test will be performed as follows: A standardized tear testing strips is placed between the eyeball and the lateral margin of the lower lid, the conjunctival sac of the patient, and the advancement of a tear film over a period of 5 minutes is noted. The Investigator traces the tear edge with a pen, measuring the shortest and longest parts. More than 10 mm of moisture on the filter paper after 5 minutes is a sign of normal tear production. Both eyes are tested at the same time and both eyes normally release the same amount of tears. The values obtained after 30 days of treatment will be compared with the baseline (day 0) values.
Serious Adverse Device Effects (SADE), Serious Adverse Events (SAE), Adverse Device Effects (ADE), Adverse Events (AE) and Device Deficiency (DD)
Time frame: 30 days
The occurrence of SADE, SAE, ADE, AE and DD will be monitored to assess the overall safety of the device
21 secondary outcomes
Tear breakup time (TBUT))
Time frame: 30 days
Foreign body sensation
Time frame: 30 days
Redness
Time frame: 30 days
Lachrymation
Time frame: 30 days
Photophobia
Time frame: 30 days
Discomfort
Time frame: 30 days
Mucus hypersecretion
Time frame: 30 days
Swelling
Time frame: 30 days
Pain/soreness
Time frame: 30 days
Stinging
Time frame: 30 days
Burning
Time frame: 30 days
Itching
Time frame: 30 days
Blurred vision
Time frame: 30 days
Stickiness of eyelashes
Time frame: 30 days
Vision changes
Time frame: 30 days
Discomfort on lens insertion
Time frame: 30 days
Discomfort on lens removal
Time frame: 30 days
Dryness on lens insertion
Time frame: 30 days
Dryness on lens removal
Time frame: 30 days
Stinging at 1st and 2nd hour after lens insertion
Time frame: 30 days
Patient General satisfaction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 17508116The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
- Background: PubMed 28827614Ang BCH, Sng JJ, Wang PXH, Htoon HM, Tong LHT. Sodium Hyaluronate in the Treatment of Dry Eye Syndrome: A Systematic Review and Meta-Analysis. Sci Rep. 2017 Aug 21;7(1):9013. doi: 10.1038/s41598-017-08534-5.
- Background: PubMed 9260563Fraser JR, Laurent TC, Laurent UB. Hyaluronan: its nature, distribution, functions and turnover. J Intern Med. 1997 Jul;242(1):27-33. doi: 10.1046/j.1365-2796.1997.00170.x.
- Background: PubMed 30149648Tampucci S, Monti D, Burgalassi S, Terreni E, Zucchetti E, Baldacci F, Chetoni P. Effect of 5-Oxo-2-Pyrrolidinecarboxylic Acid (PCA) as a New Topically Applied Agent for Dry Eye Syndrome Treatment. Pharmaceutics. 2018 Aug 25;10(3):137. doi: 10.3390/pharmaceutics10030137.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gennaro Crugliano, MD, Prof principal investigator
Ospedale San Giovanni di Dio, Crotone (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LACRIACT in people with Dry Eye and Contact Lens Acute Red Eye, run by Laboratórios Baldacci S.A at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer Test (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159569, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.