Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 12:28 PM
Study NCT ID:
NCT02510235
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2015-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate Eye Drops in Subjects With Moderate Dry Eye
Sponsor:
Dompé Farmaceutici S.p.A
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-masked, Controlled, Non-inferiority Study to Evaluate Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate in Subjects With Moderate Dry Eye.
Status:
COMPLETED
Status Verified Date:
2025-02
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:
None
Brief Summary:
The objective of the clinical investigation was to evaluate tolerability, safety and efficacy of the tested medical device, eye drop containing Lubricin 150 µg/mL, as compared with a standard sodium hyaluronate 0.13% eye drop solution in subjects with moderate dry eye disease.
Primary objective:
• Symptom Assessment in Dry Eye (SANDE)
Secondary objectives:
* Treatment-emergent adverse events (TEAEs);
* Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia);
* Tear film osmolarity;
* Assessment of best corrected distance visual acuity (BCDVA)
* Slit lamp examination (SLE) to assess the Eyelid - Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Corneal transparency, Corneal neovascularization;
* Tear film break-up time (TFBUT);
* Corneal fluorescein surface staining (scored using the Oxford scale);
* Schirmer-I test (without anaesthesia) values;
* Intraocular Pressure (IOP)
All parameters will be evaluated at screening visit, baseline (day 1), visit 3 (day 14±2) and visit 4 (day 28±4) and at follow-up (final visit) at least 7 days but not more than 9 days after the last treatment.
The results for both the SANDE questionnaire and adverse events are reported at the patient level, without distinguishing between Study Eye and Non-Study Eye. This approach reflects the overall condition and experiences of the patient rather than attributing outcomes to individual eyes.
The Study Eye was identified as the eye with the worst overall tolerability score at Visit 2 (Day 1).
Primary objective:
• Symptom Assessment in Dry Eye (SANDE)
Secondary objectives:
* Treatment-emergent adverse events (TEAEs);
* Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia);
* Tear film osmolarity;
* Assessment of best corrected distance visual acuity (BCDVA)
* Slit lamp examination (SLE) to assess the Eyelid - Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Corneal transparency, Corneal neovascularization;
* Tear film break-up time (TFBUT);
* Corneal fluorescein surface staining (scored using the Oxford scale);
* Schirmer-I test (without anaesthesia) values;
* Intraocular Pressure (IOP)
All parameters will be evaluated at screening visit, baseline (day 1), visit 3 (day 14±2) and visit 4 (day 28±4) and at follow-up (final visit) at least 7 days but not more than 9 days after the last treatment.
The results for both the SANDE questionnaire and adverse events are reported at the patient level, without distinguishing between Study Eye and Non-Study Eye. This approach reflects the overall condition and experiences of the patient rather than attributing outcomes to individual eyes.
The Study Eye was identified as the eye with the worst overall tolerability score at Visit 2 (Day 1).
Detailed Description:
This study is a multicenter, randomized, double-masked, controlled, non-inferiority study to evaluate tolerability, safety and efficacy of Lubricin eye drops versus sodium hyaluronate eye drops (Ocuyal®) administered four times a day for 4 weeks and 1 week follow-up in subjects with moderate dry eye.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIV-15-01-013105 | OTHER | EudaMed | View |