Tolerability, Safety and Efficacy of Lubricin Versus Sodium Hyaluronate Eye Drops in Patients With Moderate Dry Eye

NCT02507934 | Completed Results

• 2 other identifiers: LUB0115MDCIV-15-05-013553
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Eye Syndrome

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS)

  A global ocular tolerability score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 meant no symptoms and 100 meant the worst possible discomfort. This evaluation was to be performed before any ophthalmic assessment at each scheduled visit. Specific ocular symptoms were measured with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. The patients evaluated their symptoms using the VAS giving the value they were feeling from none to an extreme value. The VAS scale was a straight horizontal line of fixed length (100 mm). The ends were defined as the extreme limits of the parameter. Please note that Ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were "study-eyes".

  Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1

• Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study.

  TEAEs included all AEs occurring or worsening after the first dose of the IMD. These comprise AEs during the treatment and follow-up period. For TEAE the number of events was provided.

  Visit 5/Final visit/Follow up - Day 21±1

Secondary Outcomes (10)

• Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score)

  Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1

• Change From Baseline in Schirmer Test I (Without Anaesthesia)

  Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1

• Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms

  Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1

• Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms

  Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1

• Change From Baseline in OPI (Ocular Protection Index)

  Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1

Study Arms (2)

Lubricin

EXPERIMENTAL

Lubricin 150 μg/ml eye drops solution Test investigational device was instilled b.i.d. (two times a day), one drop into each eye, from day 1 to day 7±1 and, then, from 2 to 6 times a day as needed (i.e. prn), one drop into each eye, from day 7±1 to day 14±1. After the end of the treatment period, all the subjects used Vismed® 0.18% b.i.d. every 8±1 h, one drop into each eye, from day 14±1 to day 21±1. Before the start of the treatment (from day -6/-4 to day -1), the subjects were allowed to use only Nebul®, NaCl 0.9% ocular solution q.i.d. every 4±1 h, one drop into each eye.

Device: Lubricin

Sodium Hyaluronate

ACTIVE COMPARATOR

Vismed®, 0.18% sodium hyaluronate eye drops Comparator was instilled b.i.d. (two times a day), one drop into each eye, from day 1 to day 7±1 and, then, from 2 to 6 times a day as needed (i.e. prn), one drop into each eye, from day 7±1 to day 14±1. After the end of the treatment period, all the subjects used Vismed® 0.18% b.i.d. every 8±1 h, one drop into each eye, from day 14±1 to day 21±1. Before the start of the treatment (from day -6/-4 to day -1), the subjects were allowed to use only Nebul®, NaCl 0.9% ocular solution q.i.d. every 4±1 h, one drop into each eye.

Device: Sodium Hyaluronate

Interventions

Lubricin DEVICE

Lubricin 150 µg/ml eye drops

Lubricin

Sodium Hyaluronate DEVICE

Sodium hyaluronate 0.18% eye drops

Also known as: Vismed®

Sodium Hyaluronate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be checked at the screening visit (V1) within 7 days before study treatment and confirmed at baseline visit (V2):
• Patients 18 years of age or older;
• 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);
• Patients diagnosed with dry eye from at least 3 months (current use or recommended use of artificial tears for the treatment of Dry Eye);
• Average VAS score for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm;
• Corneal staining score with fluorescein \> 3 using the Oxford corneal grading system in the worst performing eye;
• Schirmer test without anaesthesia ≤ 10 mm/5 minutes in the worst performing eye;
• Tear film break-up time (TBUT) ≤ 10 seconds in the worst performing eye;
• Best corrected distance visual acuity (BCDVA) score ≥ 0.1 decimal units in both eyes at the time of study enrollment;
• 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.

You may not qualify if:

• Patients with a mild Dry Eye condition (severity level 1 according to the Report of the International Dry Eye Workshop -DEWS, 2007);
• Patients with a severe Dry Eye condition (severity level 4 according to the Report of the International Dry Eye Workshop -DEWS, 2007);
• Best corrected distance visual acuity (BCDVA) score of \< 0.1 decimal units in either eye at the time of study enrolment;
• Evidence of an active ocular infection in either eye;
• History or presence of ocular surface disorders not related to dry eye in either eye;
• Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period;
• 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;
• 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;
• 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.);
• Known hypersensitivity to one of the components of the study or procedural medications;
• Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit;
• History of drug, medication or alcohol abuse or addiction;
• 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,

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

Study Sites (1)

Dipartimento "Organi di Senso" Università La Sapienza- Policlinico Umberto I

Rome, 00161, Italy

Location

Related Publications (1)

• 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.

  PMID: 27614318 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Development & Operations
• Organization: Dompé farmaceutici SpA

clinical.trials@dompe.com

+39 02 583831

Study Officials

• Flavio Mantelli, MD-PhD

  Dompè farmaceutici SpA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The packaging used for the comparator in the present investigation aimed at ensuring a complete masking of the test IMD.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 24, 2015
• Study Start: June 26, 2015
• Primary Completion: October 5, 2015
• Study Completion: October 6, 2015
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-07

Locations

IT (1)