An interventional study of LACRIACT in Dry Eye, Contact Lens Acute Red Eye and Photophobia, sponsored by Laboratórios Baldacci S.A. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Laboratórios Baldacci S.A · Not applicable, Interventional, and Treatment
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.
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Laboratórios Baldacci S.A is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: LACRIACT
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.
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.
Time frame: 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
Time frame: 30 days
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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 30 days
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Laboratórios Baldacci S.A