An observational study in Ocular Dryness, sponsored by SIFI SpA. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by SIFI SpA · Observational
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The purpose of this study is to assess the performance and safety resulting from the treatment of an ophthalmic solution for the ocular discomfort and in particular in presence of ocular dryness.
Multicenter, prospective, observational, open-label, non- interventional clinical investigation evaluating the performance and safety of 4 daily instillations of the ophthalmic solution in the treatment of mild irritation of the ocular surface.
SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
28 male and female subjects with signs and symptoms of ocular discomfort and ocular irritation resulting from ocular dryness who qualifies for Hyalistil Bio PF treatment.
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.
Subjects with ocular discomfort resulting from mild to moderate dry eye in one or both eyes determined by:
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Moisturizing and lubricating ophthalmic solution
Tear Film Break-up Time With Fluorescein (TFBUT)
The TFBUT will be performed after instillation of 5 microliters of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient will be instructed to blink several times to thoroughly mix the fluorescein with the tear film. To achieve maximum fluorescence, the examiner should wait approximately 30 seconds after instillation before evaluating TFBUT. The TFBUT was measured by determining the time in seconds to tear break-up within 10 seconds maximum, and it was measured three time during the first minute after the instillation of fluorescein solution. The TFBUT value will be the average of 3 measurements.
Time frame: Evaluated at Visit 1 (baseline) and Visit 3 (day 35 ± 4 - study termination)
Fluorescein Staining
The NEI/Industry Workshop scale (1995) is an ophthalmological rating scale developed by the National Eye Institute (NEI, USA) to measure the degree of corneal and conjunctival staining after instillation of fluorescein or rose bengal/lissamine green. * The cornea is divided into 5 zones: Central, Superior, Inferior, Nasal, Temporal. Each zone is assigned a score from 0 to 3: 0 = no staining; 1 = mild; 2 = moderate; 3 = severe (Lower values=better outcomes - Total maximum cornea staining = 15). * The bulbar conjunctiva is divided into 6 areas: Superior nasal, Inferior nasal, Superior temporal, Inferior temporal, Superior (under the upper eyelid, less frequently assessed), Inferior (above the inferior fornix). The total maximum conjunctiva staing is 18. The total staining score is given by the sum of the corneal and conjunctival staining (Lower values=better outcomes - Min=0, Max=33).
Time frame: Evaluated at Visit 1 (baseline), Visit 2 (day 14± 2) and Visit3 (day 35 ± 4 - study termination visit)
SANDE
The SANDE questionnaire (Symptom Assessment in Dry Eye) is a very simple, validated tool to assess dry eye symptoms. It's based on two visual analog scale (VAS) questions that measure: 1) Frequency of symptoms (dry and irritated); 2) Severity of symptoms (dryness and irritation). Each question is scored by the patients on a 0-100 mm VAS line (0 = no symptoms, 100 = maximum symptoms), marking the point that they feel represents their perception of their current state. Data collected from the SANDE questionnaire were calculated by multiplying the frequency score by the severity score and obtaining the square root.
Time frame: Evaluated at Visit 1 (baseline), Visit2 (day 14± 2) and Visit3 (35 ± 4 - study termination)
Evaluation of the Degree of Satisfaction to the Treatment Reported by Patients Through the Use of the Visual Analogue Scale (VAS).
To evaluate the degree of satisfaction of patients to the treatment we used the visual analogue scale (VAS) ranging from 0 to 100 mm in a horizontal line. Patients will be asked to place a vertical mark (on the horizontal line, from 0 to100 mm) to indicate the degree of satisfaction to the treatment, where: 0-10 mm=no: 1-30 mm=very mild; 31-50 mm=mild; 51-70 mm=moderate; 71-90 mm=strong; 91-100 mm=very strong. Patients were asked to rate their level of satisfaction answering each of these questions: 1) "I feel satisfied using this treatment? ''; 2) "With this treatment, I have a feeling of freshness?"; 3) "With this treatment, I have a feeling of relief?"; 4) "This treatment contributed to reduce my pain due to eye dryness?''; 5) "This treatment is comfortable? '' The response results are expressed in frequency and percentage of the total for each of the questions in the categories "very mild", "mild", "moderate", "strong" and "very strong".
Time frame: Evaluated at day 35 ± 4 of treatment
Dry Eye-Related Quality of Life (DEQS Total Score)
Quality of life was assessed using the Dry Eye-Related Quality of Life Score (DEQS) questionnaire, which includes 15 items grouped into two subscales: Symptom Burden (6 items) and Impact on Daily Life (9 items). Each item is scored on a 0 to 4 scale, with higher scores indicating worse symptoms. Subscale scores range from 0 to 24 and 0 to 36, respectively. A total DEQS score was calculated by summing all item scores and converting the raw total to a 0-100 scale, where lower scores indicate better quality of life.
Time frame: Baseline (Visit 1) and Study Termination Visit (Day 35 ± 4)
Tear Film Break-up Time With Fluorescein (TFBUT)
The TFBUT will be performed after instillation of 5 microliters of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient will be instructed to blink several times to thoroughly mix the fluorescein with the tear film. To achieve maximum fluorescence, the examiner should wait approximately 30 seconds after instillation before evaluating TFBUT. The TFBUT was measured by determining the time in seconds to tear break-up within 10 seconds maximum, and it was measured three time during the first minute after the instillation of fluorescein solution. The TFBUT value will be the average of 3 measurements.
Time frame: Evaluated at day 14 ± 2 of treatment (Visit 2) and day 35 ± 4 of treatment (Visit 3 - Study termination)
Best Corrected Visual Acuity (BCVA)
The ETDRS chart uses a standardized, logarithmic letter chart (Sloan letters, 5 per line). Results can be reported as either logMAR values or letter scores, in our study we used the "Line method" (the smallest line where at least 3 of 5 letters are correctly read), while Visual Acuity was expressed as Snellen Distance Equivalent (meters); in the Italian decimal system, 10/10 corresponds to 6/6" or 0.0 logMAR. To maintain consistency across clinics and trials, the examination conditions were standardized as follow: Test distance 4 meters, Chart uniformly illuminated (\~85 cd/m² luminance), with a white, high contrast (≥ 90%) background, the Best corrected visual acuity (BCVA) was measured with trial frame lenses. The BCVA was testing monocularly, while the patient was encouraged to read as many letters as possible, even if guessing. When the patient misses a prespecified number (3 or more errors in a row), testing stops.
Time frame: Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline
Investigator Global Assessment of Safety (IGAS)
Safety was assessed using the Investigator Global Assessment of Safety (IGAS), a 4-point categorical scale where 1 = very good safety, 2 = good safety, 3 = moderate safety, and 4 = poor safety. IGAS was evaluated at the Study Termination Visit and summarized by reporting the number and percentage of participants in each category.
Time frame: Study Termination Visit (Day 35 ± 4)
Change in Intraocular Pressure (IOP)
Intraocular pressure (IOP) was measured in mmHg using Goldmann applanation tonometry after topical anesthesia with unpreserved 0.4 percent oxybuprocaine hydrochloride. IOP was assessed at three pre-specified study visits: baseline (Visit 1), Visit 2 during treatment, and the Study Termination Visit. Results were summarized by visit for all participants included in the intention-to-treat population.
Time frame: Baseline (Visit 1), Visit 2 (Day 14 ± 2), and Study Termination Visit (Day 35 ± 4)
Treatment Compliance Rate
Treatment compliance was assessed during the treatment period by counting returned single-dose containers and boxes at the Study Termination Visit. Compliance was calculated as the percentage of prescribed doses administered relative to planned doses for each participant. Participants were categorized into predefined compliance categories (\<50%, 50-80%, \>80%) for reporting purposes.
Time frame: During the treatment period, assessed at Study Termination Visit (Day 35 ± 4)
Subjects with signs and symptoms of ocular discomfort and ocular irritation resulting from ocular dryness / tear film alterations
| Milestone | Hyalistil Bio PF |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
The TFBUT will be performed after instillation of 5 microliters of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient will be instructed to blink several times to thoroughly mix the fluorescein with the tear film. To achieve maximum fluorescence, the examiner should wait approximately 30 seconds after instillation before evaluating TFBUT. The TFBUT was measured by determining the time in seconds to tear break-up within 10 seconds maximum, and it was measured three time during the first minute after the instillation of fluorescein solution. The TFBUT value will be the average of 3 measurements.
| Second | Hyalistil Bio PF |
|---|---|
| TFBUT at Visit 1 (Baseline) | 5.00 ± 2.03 |
| TFBUT at Visit 3 (Study termination) | 13.46 ± 5.83 |
The NEI/Industry Workshop scale (1995) is an ophthalmological rating scale developed by the National Eye Institute (NEI, USA) to measure the degree of corneal and conjunctival staining after instillation of fluorescein or rose bengal/lissamine green. * The cornea is divided into 5 zones: Central, Superior, Inferior, Nasal, Temporal. Each zone is assigned a score from 0 to 3: 0 = no staining; 1 = mild; 2 = moderate; 3 = severe (Lower values=better outcomes - Total maximum cornea staining = 15). * The bulbar conjunctiva is divided into 6 areas: Superior nasal, Inferior nasal, Superior temporal, Inferior temporal, Superior (under the upper eyelid, less frequently assessed), Inferior (above the inferior fornix). The total maximum conjunctiva staing is 18. The total staining score is given by the sum of the corneal and conjunctival staining (Lower values=better outcomes - Min=0, Max=33).
| score on a scale | Hyalistil Bio PF |
|---|---|
| Total NEI Score at Visit 1 (baseline) | 16.82 ± 5.48 |
| Total NEI Score at Visit 2 | 9.79 ± 3.45 |
| Total NEI Score at Visit 3 (Study Termination Visit) | 5.18 ± 2.46 |
The SANDE questionnaire (Symptom Assessment in Dry Eye) is a very simple, validated tool to assess dry eye symptoms. It's based on two visual analog scale (VAS) questions that measure: 1) Frequency of symptoms (dry and irritated); 2) Severity of symptoms (dryness and irritation). Each question is scored by the patients on a 0-100 mm VAS line (0 = no symptoms, 100 = maximum symptoms), marking the point that they feel represents their perception of their current state. Data collected from the SANDE questionnaire were calculated by multiplying the frequency score by the severity score and obtaining the square root.
| score on scale (millimeters) | Hyalistil Bio PF |
|---|---|
| Total score severity: Visit 1 (baseline) | 67.32 ± 16.53 |
| Total score severity: Study termination | 26.43 ± 22.15 |
| Total score frequency: Visit 1 (baseline) | 67.68 ± 17.08 |
| Total score frequency: Study termination | 27.14 ± 25.07 |
To evaluate the degree of satisfaction of patients to the treatment we used the visual analogue scale (VAS) ranging from 0 to 100 mm in a horizontal line. Patients will be asked to place a vertical mark (on the horizontal line, from 0 to100 mm) to indicate the degree of satisfaction to the treatment, where: 0-10 mm=no: 1-30 mm=very mild; 31-50 mm=mild; 51-70 mm=moderate; 71-90 mm=strong; 91-100 mm=very strong. Patients were asked to rate their level of satisfaction answering each of these questions: 1) "I feel satisfied using this treatment? ''; 2) "With this treatment, I have a feeling of freshness?"; 3) "With this treatment, I have a feeling of relief?"; 4) "This treatment contributed to reduce my pain due to eye dryness?''; 5) "This treatment is comfortable? '' The response results are expressed in frequency and percentage of the total for each of the questions in the categories "very mild", "mild", "moderate", "strong" and "very strong".
| Participants | Hyalistil Bio PF |
|---|---|
| 1) "I feel satisfied using this treatment?" — very mild | 0 |
| 1) "I feel satisfied using this treatment?" — mild | 4 |
| 1) "I feel satisfied using this treatment?" — moderate | 3 |
| 1) "I feel satisfied using this treatment?" — strong | 12 |
| 1) "I feel satisfied using this treatment?" — very strong | 8 |
| 2) "With this treatment, I have a feeling of freshness?" — very mild | 2 |
| 2) "With this treatment, I have a feeling of freshness?" — mild | 1 |
| 2) "With this treatment, I have a feeling of freshness?" — moderate | 3 |
| 2) "With this treatment, I have a feeling of freshness?" — strong | 14 |
| 2) "With this treatment, I have a feeling of freshness?" — very strong | 7 |
| 3) "With this treatment, I have a feeling of relief?" — very mild | 1 |
| 3) "With this treatment, I have a feeling of relief?" — mild | 2 |
| 3) "With this treatment, I have a feeling of relief?" — moderate | 2 |
| 3) "With this treatment, I have a feeling of relief?" — strong | 15 |
| 3) "With this treatment, I have a feeling of relief?" — very strong | 7 |
| 4) "This treatment contributed to reduce my pain due to eye dryness?'' — very mild | 0 |
| 4) "This treatment contributed to reduce my pain due to eye dryness?'' — mild | 2 |
| 4) "This treatment contributed to reduce my pain due to eye dryness?'' — moderate | 4 |
| 4) "This treatment contributed to reduce my pain due to eye dryness?'' — strong | 14 |
| 4) "This treatment contributed to reduce my pain due to eye dryness?'' — very strong | 7 |
| 5) "This treatment is comfortable? '' — very mild | 0 |
| 5) "This treatment is comfortable? '' — mild | 2 |
| 5) "This treatment is comfortable? '' — moderate | 2 |
| 5) "This treatment is comfortable? '' — strong | 11 |
| 5) "This treatment is comfortable? '' — very strong | 12 |
Quality of life was assessed using the Dry Eye-Related Quality of Life Score (DEQS) questionnaire, which includes 15 items grouped into two subscales: Symptom Burden (6 items) and Impact on Daily Life (9 items). Each item is scored on a 0 to 4 scale, with higher scores indicating worse symptoms. Subscale scores range from 0 to 24 and 0 to 36, respectively. A total DEQS score was calculated by summing all item scores and converting the raw total to a 0-100 scale, where lower scores indicate better quality of life.
| score on a scale | Hyalistil Bio PF |
|---|---|
| DEQS Summary score - Visit 1 baseline | 53.87 ± 13.44 |
| DEQS Summary score - Study Termination V | 24.08 ± 17.13 |
| DEQS Bothersome Ocular Symptoms subscale Visit 1 baseline | 56.37 ± 13.72 |
| DEQS Bothersome Ocular Symptoms subscale Study Termination Visit | 23.25 ± 16.70 |
| DEQS Impact on Daily Life subscale Visit 1 baseline | 51.96 ± 17.26 |
| DEQS Impact on Daily Life subscale Study Termination Visit | 23.81 ± 19.31 |
The TFBUT will be performed after instillation of 5 microliters of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient will be instructed to blink several times to thoroughly mix the fluorescein with the tear film. To achieve maximum fluorescence, the examiner should wait approximately 30 seconds after instillation before evaluating TFBUT. The TFBUT was measured by determining the time in seconds to tear break-up within 10 seconds maximum, and it was measured three time during the first minute after the instillation of fluorescein solution. The TFBUT value will be the average of 3 measurements.
| Second | Hyalistil Bio PF |
|---|---|
| TFBUT at Visit 2 | 10.27 ± 5.01 |
| TFBUT at Visit 3 (Study termination) | 13.46 ± 5.83 |
The ETDRS chart uses a standardized, logarithmic letter chart (Sloan letters, 5 per line). Results can be reported as either logMAR values or letter scores, in our study we used the "Line method" (the smallest line where at least 3 of 5 letters are correctly read), while Visual Acuity was expressed as Snellen Distance Equivalent (meters); in the Italian decimal system, 10/10 corresponds to 6/6" or 0.0 logMAR. To maintain consistency across clinics and trials, the examination conditions were standardized as follow: Test distance 4 meters, Chart uniformly illuminated (\~85 cd/m² luminance), with a white, high contrast (≥ 90%) background, the Best corrected visual acuity (BCVA) was measured with trial frame lenses. The BCVA was testing monocularly, while the patient was encouraged to read as many letters as possible, even if guessing. When the patient misses a prespecified number (3 or more errors in a row), testing stops.
| Participants | Hyalistil Bio PF |
|---|---|
| BCVA Visit 1 (Baseline) — BCVA = 0.6/10 (logMAR 1.2) | 1 |
| BCVA Visit 1 (Baseline) — BCVA = 6/10 (logMAR 0.2) | 2 |
| BCVA Visit 1 (Baseline) — BCVA = 9/10 (logMAR 0.05) | 2 |
| BCVA Visit 1 (Baseline) — BCVA = 10/10 (logMAR 0.0) | 23 |
| BCVA Visit 2 — BCVA = 0.6/10 (logMAR 1.2) | 1 |
| BCVA Visit 2 — BCVA = 6/10 (logMAR 0.2) | 2 |
| BCVA Visit 2 — BCVA = 9/10 (logMAR 0.05) | 2 |
| BCVA Visit 2 — BCVA = 10/10 (logMAR 0.0) | 23 |
| BCVA Study Termination Visit — BCVA = 0.6/10 (logMAR 1.2) | 1 |
| BCVA Study Termination Visit — BCVA = 6/10 (logMAR 0.2) | 2 |
| BCVA Study Termination Visit — BCVA = 9/10 (logMAR 0.05) | 1 |
| BCVA Study Termination Visit — BCVA = 10/10 (logMAR 0.0) | 24 |
Safety was assessed using the Investigator Global Assessment of Safety (IGAS), a 4-point categorical scale where 1 = very good safety, 2 = good safety, 3 = moderate safety, and 4 = poor safety. IGAS was evaluated at the Study Termination Visit and summarized by reporting the number and percentage of participants in each category.
| Participants | Hyalistil Bio PF |
|---|---|
| Point scale 1 (very good safety) | 27 |
| Point scale 2 (good safety) | 0 |
| Point scale 3 (moderate safety) | 0 |
| Point scale 4 (poor safety) | 0 |
Intraocular pressure (IOP) was measured in mmHg using Goldmann applanation tonometry after topical anesthesia with unpreserved 0.4 percent oxybuprocaine hydrochloride. IOP was assessed at three pre-specified study visits: baseline (Visit 1), Visit 2 during treatment, and the Study Termination Visit. Results were summarized by visit for all participants included in the intention-to-treat population.
| millimeters of mercury | Hyalistil Bio PF |
|---|---|
| IOP - Visit 1 | 12.86 ± 2.00 |
| IOP - Visit 2 | 12.82 ± 1.44 |
| IOP - Visit 3 Study termination Visit | 12.61 ± 1.32 |
Treatment compliance was assessed during the treatment period by counting returned single-dose containers and boxes at the Study Termination Visit. Compliance was calculated as the percentage of prescribed doses administered relative to planned doses for each participant. Participants were categorized into predefined compliance categories (\<50%, 50-80%, \>80%) for reporting purposes.
| Participants | Hyalistil Bio PF |
|---|---|
| < 50% = Poor Compliance | 1 |
| 50-80% = Moderate Compliance | 2 |
| > 80% = Good Compliance | 25 |
Collected over The period of time that Adverse Event (AEs) data were collected for a maximum of 37 days. The Time Frame for all participant was from enrollment until end of follow-up. Specifically, for the ITT population (days/number of participants): 14/1 (missing), 33/7, 34/11, 35/6, 36/1, 37/2; for PP population (days/number of participants): 32/1, 33/7, 34/9, 35/5, 36/1 and 37/2.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hyalistil Bio PF | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Categorical(Participants) | Hyalistil Bio PF |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 10 |
| Age, Continuous(years) | Hyalistil Bio PF |
|---|---|
| Mean | 58.46 ± 55.50 |
| Sex: Female, Male(Participants) | Hyalistil Bio PF |
|---|---|
| Female | 20 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | Hyalistil Bio PF |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Hyalistil Bio PF |
|---|---|
| Italy | 28 |
| TFBUT (Tear Film Break Up Time)(Second) | Hyalistil Bio PF |
|---|---|
| Mean | 5 ± 2.03 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Mar 2023 to primary completion in Aug 2023, 4 months.
Results were first posted in Jan 2026, 2 years 5 months after primary completion.
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