Clinical Trial: Tolerability, Safety and Efficacy of Lubricin (150 µg/ml) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops in Patients With Moderate Dry Eye (DE)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 2 Week, Randomized, Double-masked, Controlled, Parallel Group and 1 Week Follow-up Study to Evaluate Tolerability, Safety and Efficacy of Lubricin (150 µg/ml) Eye Drops Versus Sodium Hyaluronat
Brief Summary:
Dry eye is 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 inflammation of the ocular surface.
Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted product of cells that line the joint tissues, which is present at the surface of articular cartilage and it has been investigated on its roles at the ocular surface, in normal and pathologic conditions such as dry eye.
The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution in subjects with moderate dry eye.
Detailed Summary:
Dry eye, or keratoconjunctivitis sicca, is a chronic inflammatory condition of the ocular surface that may cause severe symptoms an 2007 international dry eye workshop (DEWS) defined the disease as follows: "Dry eye is a multifactorial disease of the tears and oc symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied the tear film and inflammation of the ocular surface".
Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted product of cells that line the joint tissues, surface of articular cartilage.
In vitro studies have shown that lubricin in saline buffer acts as a lubricant between various surfaces, as well as in synovial fluid, pr lubricin is a principal lubricating protein in joints. Besides the lubricating property, lubricin has been shown to exert anti-adhesive ac dissipation, and a protective effect on underlying cells.
Lubricin has been investigated on its roles at the ocular surface, in normal and pathologic conditions such as dry eye. In fact, Lubricin is the protein with most potent lubricant and anti-adhesive properties present on the ocular surface and on meibomian gland. The presence on the ocular surface was first described by the team of Sullivan D.
Based on the available preclinical studies lubricin may be an important barrier to the development of corneal and conjunctival epitheliopathies in dry eyes and its use as a novel lubricating and anti-adhesive eye drop is under investigation in this clinical investigation. A clinical investigation is currently ongoing to demonstrate that a Lubricin 150 µg/ml eye drop formulation is non-inferior to an ocular surface lubricant sodium h
Sponsor: Dompé Farmaceutici S.p.A
Current Primary Outcome:
- PTAE (pre-treatment adverse events) [ Time Frame: Screening ]Pre-treatment Adverse Events
- Foreign body sensation (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Foreign body sensation (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Burning/Stinging (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Burning/Stinging (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Itching (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Itching (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Pain (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Pain (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Sticky fe
Original Primary Outcome:
- PTAE [ Time Frame: Screening ]Pre-treatment Adverse Events
- Foreign body sensation (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Foreign body sensation (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Burning/Stinging (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Burning/Stinging (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Itching (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Itching (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Pain (VAS for Local Ocular Tolerability) [ Time Frame: Baseline (Day 1) ]VAS for Local Ocular Tolerability
- Pain (VAS for Local Ocular Tolerability) [ Time Frame: Day 14 ]VAS for Local Ocular Tolerability
- Sticky feeling (VAS for Local Ocular Tol
Current Secondary Outcome:
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: Screening ]Corneal fluorescein surface staining (Oxford score)
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: Baseline (Day 1) ]Corneal fluorescein surface staining (Oxford score)
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: Day 14 ]Corneal fluorescein surface staining (Oxford score)
- TFBUT (Tear Film Break Up Time) [ Time Frame: Screening ]Tear Film Break Up Time
- TFBUT (Tear Film Break Up Time) [ Time Frame: Baseline (Day 1) ]Tear Film Break Up Time
- TFBUT (Tear Film Break Up Time) [ Time Frame: Day 14 ]Tear Film Break Up Time
- SANDE (Symptom Assessment in Dry Eye) [ Time Frame: Screening ]Symptom Assessment in Dry Eye
- SANDE (Symptom Assessment in Dry Eye) [ Time Frame: Baseline (Day 1) ]Symptom Assessment in Dry Eye
- SANDE (Symptom Assessment in Dry Eye) [ Time Frame: Day 14 ]Symptom Assessment in Dry Eye
- Schirmer Test I (without anaesthesia) [ Time Frame: Screening ]Schirmer's test I (without anaesthesia)
- Schirmer Test I (without anaesthesia) [ Time Frame: Baseline (Day 1) ]Schirmer's test I (without anaesthesia)
- Schirmer Test I (without anaesthesia) [ Time Frame: Day 14 ]Schirmer's test I (without anaesthesia)
- Best corrected distance visual acuity (ETDRS Score) [ Time Frame: Screening ]Best corrected distance visual acuity
- Best corrected distance visual acuity (ETDRS Score) [ Time Frame: Baseline (Day 1) ]Best corrected distance visual acuity
- Best corrected distance visual acuity (ETDRS Score) [ Time Frame: Day 14 ]Best corrected distance visual acuity
Original Secondary Outcome:
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: Screening ]Corneal fluorescein surface staining (Oxford score)
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: Baseline (Day 1) ]Corneal fluorescein surface staining (Oxford score)
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: Day 14 ]Corneal fluorescein surface staining (Oxford score)
- TFBUT [ Time Frame: Screening ]Tear Film Break Up Time
- TFBUT [ Time Frame: Baseline (Day 1) ]Tear Film Break Up Time
- TFBUT [ Time Frame: Day 14 ]Tear Film Break Up Time
- SANDE [ Time Frame: Screening ]Symptom Assessment in Dry Eye
- SANDE [ Time Frame: Baseline (Day 1) ]Symptom Assessment in Dry Eye
- SANDE [ Time Frame: Day 14 ]Symptom Assessment in Dry Eye
- ST I (without anaesthesia) [ Time Frame: Screening ]Schirmer's test I (without anaesthesia)
- ST I (without anaesthesia) [ Time Frame: Baseline (Day 1) ]Schirmer's test I (without anaesthesia)
- ST I (without anaesthesia) [ Time Frame: Day 14 ]Schirmer's test I (without anaesthesia)
- BCDVA [ Time Frame: Screening ]Best corrected distance visual acuity
- BCDVA [ Time Frame: Baseline (Day 1) ]Best corrected distance visual acuity
- BCDVA [ Time Frame: Day 14±2 ]Best corrected distance visual acuity
Information By: Dompé Farmaceutici S.p.A
Dates:
Date Received: July 23, 2015
Date Started: June 2015
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: Screening ]
- PTAE [ Time Frame: Screening ]
