Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate Eye Drops in Subjects With Moderate Dry Eye

The objective of the clinical investigation was to evaluate tolerability, safety and efficacy of the tested medical device, eye drop containing Lubricin 150 µg/mL, as compared with a standard sodium hyaluronate 0.13% eye drop solution in subjects with moderate dry eye disease.

Primary objective:

• Symptom Assessment in Dry Eye (SANDE)

Secondary objectives:

* Treatment-emergent adverse events (TEAEs);
* Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia);
* Tear film osmolarity;
* Assessment of best corrected distance visual acuity (BCDVA)
* Slit lamp examination (SLE) to assess the Eyelid - Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Corneal transparency, Corneal neovascularization;
* Tear film break-up time (TFBUT);
* Corneal fluorescein surface staining (scored using the Oxford scale);
* Schirmer-I test (without anaesthesia) values;
* Intraocular Pressure (IOP)

All parameters will be evaluated at screening visit, baseline (day 1), visit 3 (day 14±2) and visit 4 (day 28±4) and at follow-up (final visit) at least 7 days but not more than 9 days after the last treatment.

The results for both the SANDE questionnaire and adverse events are reported at the patient level, without distinguishing between Study Eye and Non-Study Eye. This approach reflects the overall condition and experiences of the patient rather than attributing outcomes to individual eyes.

The Study Eye was identified as the eye with the worst overall tolerability score at Visit 2 (Day 1).

This study is a multicenter, randomized, double-masked, controlled, non-inferiority study to evaluate tolerability, safety and efficacy of Lubricin eye drops versus sodium hyaluronate eye drops (Ocuyal®) administered four times a day for 4 weeks and 1 week follow-up in subjects with moderate dry eye.

Eligibility Criteria:
Inclusion Criteria:

To be checked at the screening visit (V1) from day -14 to day -8 days before run-in period and confirmed at baseline visit (V2):

1. Subjects 18 years of age or older.
2. Subjects with moderate dry eye characterized by tear film osmolarity \> 312 mOsm
3. Subjects with both VAS for frequency and severity of symptoms, SANDE items, at screening \& baseline \> 25 mm (SANDE overall score \> 25 mm).
4. Subjects 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)
5. Subjects diagnosed with dry eye from at least 6 months (current use or recommended use of artificial tears/lubricants for the treatment of Dry Eye)
6. Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units in both eyes at the time of study enrolment.
7. The Informed Consent form approved by the Ethics Committees should be signed by the subject before any study procedures.

Exclusion Criteria:

1. Evidence of an active ocular infection in either eye
2. History or presence of ocular surface disorders not related to dry eye in either eye
3. History or evidence of eyelid abnormality in either eye
4. 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
5. 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
6. 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 vasculitis, collagen vascular diseases, poorly controlled diabetes, autoimmune disease, systemic infection.)
7. Known hypersensitivity to one of the components of the test device or the comparator
8. Participation in another clinical study at the same time as the present study or within 90 days of baseline visit
9. History of drug, medication or alcohol abuse or addiction.
10. 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 IUD during the entire course of and 30 days after the study treatment periods.