Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT02507934
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tolerability, Safety and Efficacy of Lubricin Versus Sodium Hyaluronate Eye Drops in Patients With Moderate Dry Eye
Sponsor:
Dompé Farmaceutici S.p.A
Organization:
Study Overview
Official Title:
2 Week, Randomized, Double-masked, Controlled, Parallel Group+1 Week Follow-up Study to Evaluate Tolerability, Safety and Efficacy of Lubricin 150 µg/ml vs Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients With Moderate Dry Eye
Status:
COMPLETED
Status Verified Date:
2024-07
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 this study is to evaluate tolerability, safety and efficacy of Lubricin 150 µg/ml eye drops when compared to a widely used commercial 0.18% sodium hyaluronate eye drop formulation in moderate dry eye patients.
Primary objectives:
* Tolerability using a Visual Analogue Scale (VAS) for foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision, and photophobia;
* Treatment-emergent adverse events (TEAEs), assessed throughout the clinical investigation.
Secondary objectives:
* Corneal fluorescein staining (scored using the Oxford scale);
* Schirmer test type I (without anaesthesia);
* Symptom assessment in dry eye (SANDE);
* Ocular protection index (OPI);
* Tear film break-up time (TFBUT);
* Best corrected distance visual acuity (BCDVA);
* Slit lamp examination (SLE) (Eyelid - Meibomian glands, eyelid erythema, eyelid oedema, lashes, conjunctiva erythema, lens, iris, anterior chamber, corneal transparency, corneal neovascularisation);
* Intraocular pressure (IOP);
* Number of instillations of investigational medical device during the second week of the clinical investigation.
All parameters will be evaluated at Screening visit-V1 (Day -7 up to day -5), baseline visit-V2 (Day 1), V3 (Day 7±1), V4 (Day 14±1) and at Final Visit follow-up-V5 (Day 21±1).
Primary objectives:
* Tolerability using a Visual Analogue Scale (VAS) for foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision, and photophobia;
* Treatment-emergent adverse events (TEAEs), assessed throughout the clinical investigation.
Secondary objectives:
* Corneal fluorescein staining (scored using the Oxford scale);
* Schirmer test type I (without anaesthesia);
* Symptom assessment in dry eye (SANDE);
* Ocular protection index (OPI);
* Tear film break-up time (TFBUT);
* Best corrected distance visual acuity (BCDVA);
* Slit lamp examination (SLE) (Eyelid - Meibomian glands, eyelid erythema, eyelid oedema, lashes, conjunctiva erythema, lens, iris, anterior chamber, corneal transparency, corneal neovascularisation);
* Intraocular pressure (IOP);
* Number of instillations of investigational medical device during the second week of the clinical investigation.
All parameters will be evaluated at Screening visit-V1 (Day -7 up to day -5), baseline visit-V2 (Day 1), V3 (Day 7±1), V4 (Day 14±1) and at Final Visit follow-up-V5 (Day 21±1).
Detailed Description:
This study is a 2 week, randomized, double-masked, controlled, parallel group and 1 week follow-up investigation to evaluate tolerability, safety and efficacy of Lubricin (150 µg/mL) eye drops versus sodium hyaluronate (HA) 0.18% eye drops (Vismed®) in patients with moderate dry eye (DE).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-15-05-013553 | OTHER | EudaMed | View |