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)

Dry Eye Syndrome Clinical Trial

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 Hyaluronate (HA) 0.18% Eye Drops in Patients With Moderate Dry Eye (DE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507934
• Other study ID #: LUB0115MD
• Status: Completed
• Phase: N/A
• First received: July 23, 2015
• Last updated: January 26, 2016
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Dompé Farmaceutici S.p.A
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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 hyaluronate 0.13%.

Up to now, there are no known anticipated adverse events associated with the use of lubricin, anyway the occurrence of side effect It must be considered that topical treatment with lubricin or hyaluronic acid could cause local irritation or allergic reactions. There ar contraindications to the use of lubricin or hyaluronic acid eye drops. All examinations and assessments that will be carried out durin invasive, are commonly used in the management of subjects with dry eye and pose no risk to the subjects. There are no known co lubricin or hyaluronic acid eye drops. . No data are available about the embryo and fetal toxicity, therefore the experimental treatment will not be allowed to pregnant women or nursing mothers and women of childbearing potential not using appropriate birth control methods.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be checked at the screening visit (V1) within 7 days before study treatment and confirmed at baseline visit (V2):

1. Patients 18 years of age or older.

2. Patients with moderate dry eye characterized by at least one eye with signs and symptoms of moderate dry eye (grade 2 or 3 of the 2007 DEWS report)

3. Patients diagnosed with dry eye from at least 3 months (current use or recommended use of artificial tears for the treatment of Dry Eye)

4. Average VAS score for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) = 25 mm;

5. Corneal staining score with fluorescein > 3 using the Oxford corneal grading system in the worst performing eye;

6. Schirmer test without anaesthesia = 10 mm/5 minutes in the worst performing eye;

7. Tear film break-up time (TBUT) = 10 seconds in the worst performing eye

8. Best corrected distance visual acuity (BCDVA) score = 0.1 decimal units in both eyes at the time of study enrollment.

9. Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the Ethics Committee for the current study.

Exclusion Criteria:

1. Patients with a mild Dry Eye condition (severity level 1 according to the Report of the International Dry Eye Workshop -DEWS, 2007)

2. Patients with a severe Dry Eye condition (severity level 4 according to the Report of the International Dry Eye Workshop -DEWS, 2007)

3. Best corrected distance visual acuity (BCDVA) score of < 0.1 decimal units in either eye at the time of study enrolment

4. Evidence of an active ocular infection in either eye

5. History or presence of ocular surface disorders not related to dry eye in either eye

6. Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period

7. Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment

8. History of any ocular surgery (including laser or refractive surgical procedures) in either eye within the 90 days before study enrolment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period

9. Presence or history of any ocular or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trail procedures (e.g. ocular trauma, progressive or degenerative corneal conditions, uveitis, systemic infection.)

10. Known hypersensitivity to one of the components of the study or procedural medications

11. Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit

12. History of drug, medication or alcohol abuse or addiction.

13. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:

• are currently pregnant or,

• have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,

• intend to become pregnant during the study treatment period or,

• are breast-feeding or,

• not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or an Intra Uterine Device during the entire course of and 30 days after the study treatment periods.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Lubricin
Lubricin 150 µg/ml eye drops
• Sodium Hyaluronate
Sodium hyaluronate 0.18% eye drops

Locations

Country	Name	City	State
Italy	Dipartimento "Organi di Senso" Università La Sapienza- Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Dompé Farmaceutici S.p.A

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTAE (pre-treatment adverse events)	Pre-treatment Adverse Events	Screening	Yes
Primary	Foreign body sensation (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Baseline (Day 1)	Yes
Primary	Foreign body sensation (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Day 14	Yes
Primary	Burning/Stinging (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Baseline (Day 1)	Yes
Primary	Burning/Stinging (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Day 14	Yes
Primary	Itching (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Baseline (Day 1)	Yes
Primary	Itching (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Day 14	Yes
Primary	Pain (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Baseline (Day 1)	Yes
Primary	Pain (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Day 14	Yes
Primary	Sticky feeling (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Baseline (Day 1)	Yes
Primary	Sticky feeling (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Day 14	Yes
Primary	Blurred vision (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Baseline (Day 1)	Yes
Primary	Blurred vision (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Day 14	Yes
Primary	Photophobia (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Baseline (Day 1)	Yes
Primary	Photophobia (VAS for Local Ocular Tolerability)	VAS for Local Ocular Tolerability	Day 14	Yes
Primary	TEAE (treatment-emergent adverse events)	Treatment-emergent Adverse Events	Baseline (Day 1)	Yes
Primary	TEAE (treatment-emergent adverse events)	Treatment-emergent Adverse Events	Day 7	Yes
Primary	TEAE (treatment-emergent adverse events)	Treatment-emergent Adverse Events	Day 14	Yes
Primary	TEAE (treatment-emergent adverse events)	Treatment-emergent Adverse Events	Follo-up (Day 21)	Yes
Secondary	Corneal fluorescein surface staining (Oxford score)	Corneal fluorescein surface staining (Oxford score)	Screening	No
Secondary	Corneal fluorescein surface staining (Oxford score)	Corneal fluorescein surface staining (Oxford score)	Baseline (Day 1)	No
Secondary	Corneal fluorescein surface staining (Oxford score)	Corneal fluorescein surface staining (Oxford score)	Day 14	No
Secondary	TFBUT (Tear Film Break Up Time)	Tear Film Break Up Time	Screening	No
Secondary	TFBUT (Tear Film Break Up Time)	Tear Film Break Up Time	Baseline (Day 1)	No
Secondary	TFBUT (Tear Film Break Up Time)	Tear Film Break Up Time	Day 14	No
Secondary	SANDE (Symptom Assessment in Dry Eye)	Symptom Assessment in Dry Eye	Screening	No
Secondary	SANDE (Symptom Assessment in Dry Eye)	Symptom Assessment in Dry Eye	Baseline (Day 1)	No
Secondary	SANDE (Symptom Assessment in Dry Eye)	Symptom Assessment in Dry Eye	Day 14	No
Secondary	Schirmer Test I (without anaesthesia)	Schirmer's test I (without anaesthesia)	Screening	No
Secondary	Schirmer Test I (without anaesthesia)	Schirmer's test I (without anaesthesia)	Baseline (Day 1)	No
Secondary	Schirmer Test I (without anaesthesia)	Schirmer's test I (without anaesthesia)	Day 14	No
Secondary	Best corrected distance visual acuity (ETDRS Score)	Best corrected distance visual acuity	Screening	No
Secondary	Best corrected distance visual acuity (ETDRS Score)	Best corrected distance visual acuity	Baseline (Day 1)	No
Secondary	Best corrected distance visual acuity (ETDRS Score)	Best corrected distance visual acuity	Day 14	No