Clinical trial NCT02507934: Tolerability, Safety and Efficacy of Lubricin Versus Sodium Hyaluronate Eye Drops in Patients With Moderate Dry Eye
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry Eye
Lead sponsor: Dompé Farmaceutici S.p.A
Sponsor class: INDUSTRY
First posted: 2015-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS)
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study.
timeFrame: Visit 5/Final visit/Follow up - Day 21±1
Secondary outcomes:
measure: Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score)
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in Schirmer Test I (Without Anaesthesia)
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in OPI (Ocular Protection Index)
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in TFBUT (Tear Film Break Up Time)
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in Slit Lamp Examination (SLE)
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Change From Baseline in IOP (Intraocular Pressure)
timeFrame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
measure: Number of Instillations of IMD During the Second Week of the Clinical Investigation
timeFrame: from Visit 3 - Day 7±1 to Visit 4 - Day 14±1
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Dipartimento "Organi di Senso" Università La Sapienza- Policlinico Umberto I
Study officials:
affiliation: Dompè farmaceutici SpA
name: Flavio Mantelli, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Lambiase A, Sullivan BD, Schmidt TA, Sullivan DA, Jay GD, Truitt ER 3rd, Bruscolini A, Sacchetti M, Mantelli F. A Two-Week, Randomized, Double-masked Study to Evaluate Safety and Efficacy of Lubricin (150 mug/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease. Ocul Surf. 2017 Jan;15(1):77-87. doi: 10.1016/j.jtos.2016.08.004. Epub 2016 Sep 8.