Clinical trial NCT03031327: Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.
Official title: A 2 Weeks, Randomized, Double-masked, Controlled Study to Assess Tolerability, Safety, Permanence on the Ocular Surface, Efficacy of Lubricin (20 and 50 μg/ml) vs Sodium Hyaluronate 0.18% in Ocular Discomfort Following Refractive Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Discomfort
Keywords: Ocular Discomfort Following Refractive Surgery
Refractive Surgery
sodium hyaluronate
HA
Vismed®
Lubricin
Lead sponsor: Dompé Farmaceutici S.p.A
Sponsor class: INDUSTRY
First posted: 2017-01-25
Enrollment: 30
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 was to evaluate tolerability, safety, permanence on the ocular surface and efficacy of Lubricin (20 and 50 μg/mL) eye drops vs Sodium Hyaluronate (Vismed®) 0.18% eye drops in patients with ocular discomfort following refractive surgery.

Primary objectives:

* Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia;
* Treatment-emergent adverse events (TEAEs), assessed throughout the study.

Secondary objectives:

* Ocular surface vital staining with Fluorescein (Oxford scale)
* Schirmer-I test (without anaesthesia);
* Permanence of Lubricin on the Ocular Surface Tear film break-up time (TFBUT);
* Best corrected distance visual acuity (BCDVA);
* SANDE questionnaire scores - discomfort improvement entity;
* SANDE questionnaire scores - discomfort improvement speed;
* Signs evaluated by Slit lamp examination (SLE) (blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia);
* Intraocular pressure (IOP) ;
* Corneal sensitivity by Cochet-Bonnet aesthesiometry.

All parameters were evaluated at V1 (Day 1 - Baseline), V2 (Day 15±2) and V3 (Day 22±2/ETV).

Detailed description: This study was a 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study to evaluate tolerability, safety, permanence on the ocular surface and efficacy of Lubricin (20 and 50 μg/mL) eye drops vs Sodium Hyaluronate (Vismed®) 0.18% eye drops in patients with ocular discomfort following refractive surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older;
2. Patients undergone ocular refractive surgery within 6 months from V1 - Day 1;
3. Patients with ocular discomfort defined as SANDE score ≥ 30 at baseline;
4. Average VAS score (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm;
5. Best corrected distance visual acuity (BCDVA) score ≥ 0.1 decimal units in both eyes at the time of study enrolment;
6. 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 severe Dry Eye condition (severity level 4 according to the Report of the International Dry Eye Workshop -DEWS, 2007);
2. Best corrected distance visual acuity (BCDVA) score of \< 0.1 decimal units in either eye at the time of study enrolment;
3. Evidence of an active ocular infection in either eye;
4. History or presence of ocular surface disorders other than ocular discomfort in either eye;
5. Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period;
6. 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;
7. History of any ocular surgery (excluding laser or refractive surgical procedures) in either eye within 30 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;
8. Known hypersensitivity to one of the components of the study or procedural medications;
9. Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit;
10. History of drug, medication or alcohol abuse or addiction;
11. 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:

    1. are currently pregnant or,
    2. have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
    3. intend to become pregnant during the study treatment period or,
    4. are breast-feeding or,
    5. 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 (intrauterine device ) during the entire course of and 30 days after the study treatment periods.

Primary outcomes:
measure: Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS)
timeFrame: Day 1 (baseline = Visit 1) at pre-dose, 15, 30 min post-dose; Day 15±2 (= Visit 2) at pre-dose, 15, 30 min post-dose; Day 22±2 (= Visit 3)
measure: Treatment-emergent Adverse Events (TEAEs) Assessed Throughout the Study
timeFrame: From baseline (Day 1 - pre-dose) to day 22±2
Secondary outcomes:
measure: Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale)
timeFrame: Day 15±2 (Visit 2); Day 22±2 (Visit 3)
measure: Change From Baseline in Schirmer-I Test (Without Anaesthesia)
timeFrame: Day 15±2 (Visit 2); Day 22±2 (Visit 3)
measure: Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT)
timeFrame: Day 15±2 (Visit 2); Day 22±2 (Visit 3)
measure: Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score
timeFrame: Day 15±2 (Visit 2); Day 22±2 (Visit 3)
measure: Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores
timeFrame: Day 15±2 (Visit 2); Day 22±2 (Visit 3)
measure: Change From Baseline in Slit Lamp Examination (SLE) Values
timeFrame: Day 15±2 (Visit 2); Day 22±2 (Visit 3)
measure: Change From Baseline in IOP (Intraocular Pressure)
timeFrame: Day 15±2 (Visit 2); Day 22±2 (Visit 3)
measure: Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry
timeFrame: From baseline (Day 1 pre-dose) to Day 15±2 and Day 22±2
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Dipartimento "Organi di senso" Università La Sapienza- Policlinico Umberto I
Study officials:
affiliation: Dompé Farmaceutici S.p.A
name: Flavio Mantelli, MD-PhD
role: STUDY_DIRECTOR
References: