18 and older, any sex, with Ocular Dryness. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Tear Film Break-up Time With Fluorescein (TFBUT)Primary· Evaluated at Visit 1 (baseline) and Visit 3 (day 35 ± 4 - study termination)
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
TFBUT at Visit 1 (Baseline)
Group
Value
95% CI
Hyalistil Bio PF
5.00
± 2.03
TFBUT at Visit 3 (Study termination)
Group
Value
95% CI
Hyalistil Bio PF
13.46
± 5.83
Fluorescein StainingSecondary· Evaluated at Visit 1 (baseline), Visit 2 (day 14± 2) and Visit3 (day 35 ± 4 - study termination visit)
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,
Total NEI Score at Visit 1 (baseline)
Group
Value
95% CI
Hyalistil Bio PF
16.82
± 5.48
Total NEI Score at Visit 2
Group
Value
95% CI
Hyalistil Bio PF
9.79
± 3.45
Total NEI Score at Visit 3 (Study Termination Visit)
Group
Value
95% CI
Hyalistil Bio PF
5.18
± 2.46
SANDESecondary· Evaluated at Visit 1 (baseline), Visit2 (day 14± 2) and Visit3 (35 ± 4 - study termination)
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 obta
Total score severity: Visit 1 (baseline)
Group
Value
95% CI
Hyalistil Bio PF
67.32
± 16.53
Total score severity: Study termination
Group
Value
95% CI
Hyalistil Bio PF
26.43
± 22.15
Total score frequency: Visit 1 (baseline)
Group
Value
95% CI
Hyalistil Bio PF
67.68
± 17.08
Total score frequency: Study termination
Group
Value
95% CI
Hyalistil Bio PF
27.14
± 25.07
Evaluation of the Degree of Satisfaction to the Treatment Reported by Patients Through the Use of the Visual Analogue Scale (VAS).Secondary· Evaluated at day 35 ± 4 of treatment
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 f
1) "I feel satisfied using this treatment?"
Group
Value
95% CI
Hyalistil Bio PF
0
Hyalistil Bio PF
4
Hyalistil Bio PF
3
Hyalistil Bio PF
12
2) "With this treatment, I have a feeling of freshness?"
Group
Value
95% CI
Hyalistil Bio PF
2
Hyalistil Bio PF
1
Hyalistil Bio PF
3
Hyalistil Bio PF
14
3) "With this treatment, I have a feeling of relief?"
Group
Value
95% CI
Hyalistil Bio PF
1
Hyalistil Bio PF
2
Hyalistil Bio PF
2
Hyalistil Bio PF
15
4) "This treatment contributed to reduce my pain due to eye dryness?''
Group
Value
95% CI
Hyalistil Bio PF
0
Hyalistil Bio PF
2
Hyalistil Bio PF
4
Hyalistil Bio PF
14
5) "This treatment is comfortable? ''
Group
Value
95% CI
Hyalistil Bio PF
0
Hyalistil Bio PF
2
Hyalistil Bio PF
2
Hyalistil Bio PF
11
Dry Eye-Related Quality of Life (DEQS Total Score)Secondary· Baseline (Visit 1) and Study Termination Visit (Day 35 ± 4)
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.
DEQS Bothersome Ocular Symptoms subscale Study Termination Visit
Group
Value
95% CI
Hyalistil Bio PF
23.25
± 16.70
DEQS Impact on Daily Life subscale Visit 1 baseline
Group
Value
95% CI
Hyalistil Bio PF
51.96
± 17.26
DEQS Impact on Daily Life subscale Study Termination Visit
Group
Value
95% CI
Hyalistil Bio PF
23.81
± 19.31
Tear Film Break-up Time With Fluorescein (TFBUT)Secondary· Evaluated at day 14 ± 2 of treatment (Visit 2) and day 35 ± 4 of treatment (Visit 3 - Study termination)
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
TFBUT at Visit 2
Group
Value
95% CI
Hyalistil Bio PF
10.27
± 5.01
TFBUT at Visit 3 (Study termination)
Group
Value
95% CI
Hyalistil Bio PF
13.46
± 5.83
Best Corrected Visual Acuity (BCVA)Secondary· Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline
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), wit
BCVA Visit 1 (Baseline)
Group
Value
95% CI
Hyalistil Bio PF
1
Hyalistil Bio PF
2
Hyalistil Bio PF
2
Hyalistil Bio PF
23
BCVA Visit 2
Group
Value
95% CI
Hyalistil Bio PF
1
Hyalistil Bio PF
2
Hyalistil Bio PF
2
Hyalistil Bio PF
23
BCVA Study Termination Visit
Group
Value
95% CI
Hyalistil Bio PF
1
Hyalistil Bio PF
2
Hyalistil Bio PF
1
Hyalistil Bio PF
24
Investigator Global Assessment of Safety (IGAS)Secondary· Study Termination Visit (Day 35 ± 4)
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.
Group
Value
95% CI
Hyalistil Bio PF
27
Hyalistil Bio PF
0
Hyalistil Bio PF
0
Hyalistil Bio PF
0
Change in Intraocular Pressure (IOP)Secondary· Baseline (Visit 1), Visit 2 (Day 14 ± 2), and Study Termination Visit (Day 35 ± 4)
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.
IOP - Visit 1
Group
Value
95% CI
Hyalistil Bio PF
12.86
± 2.00
IOP - Visit 2
Group
Value
95% CI
Hyalistil Bio PF
12.82
± 1.44
IOP - Visit 3 Study termination Visit
Group
Value
95% CI
Hyalistil Bio PF
12.61
± 1.32
Treatment Compliance RateSecondary· During the treatment period, assessed at Study Termination Visit (Day 35 ± 4)
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.
Group
Value
95% CI
Hyalistil Bio PF
1
Hyalistil Bio PF
2
Hyalistil Bio PF
25
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by SIFI SpA
Last refreshed: 7 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05777798.