A 2 Weeks Study to Evaluate Tolerability, Safety, Permanence on the Ocular Surface and Efficacy of Two Concentrations of Lubricin Eye Drops Versus Sodium Hyaluronate 0.18% Eye Drops in Patients With Ocular Discomfort Following Refractive Surgery

Study Overview
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Brief Summary
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A 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study. Patients with ocular discomfort following refractive surgery procedure (within 6 months from enrollment into the investigation) will be evaluated at baseline (Day 1), at Week 2 (day 15±2 days) and at Week 3 follow-up visit (day 22±2, or early exit).

Detailed Description
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Thirty (30) patients (10 per arm) randomized 1:1:1 to Lubricin 20 µg/ml eye drops solution or Lubricin 50 µg/ml eye drops solution or sodium hyaluronate (HA) 0.18% eye drops solution will be enrolled. As the primary objective of this study is to evaluate the tolerability and safety of Lubricin (20 and 50 μg/mL) eye drops solution administered over 2 weeks in patients with ocular discomfort following ocular refractive surgery, sample size was calculated based on clinical feasibility and no formal sample size calculation has been performed.

Official Title
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A 2 Week, Randomized, Double-masked, Controlled, Parallel Group Study to Evaluate Tolerability, Safety, Permanence on the Ocular Surface and Efficacy of Two Concentrations of Lubricin (20 and 50 μg/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients With Ocular Discomfort Following Refractive Surgery

Conditions
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Ocular Discomfort

Intervention / Treatment
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* Device: Lubricin 20µg/ml eye drops
* Device: Lubricin 50µg/ml eye drops
* Device: Sodium hyaluronate (HA) 0.18% eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older. Patients undergone ocular refractive surgery within 6 months from Day 1 Visit. Patients with ocular discomfort defined as SANDE score ≥ 30 at baseline. Average VAS score (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm; Best corrected distance visual acuity (BCDVA) score ≥ 0.1 decimal units in both eyes at the time of study enrolment. 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: 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 other than ocular discomfort 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 (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 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, 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 (intrauterine device ) during the entire course of and 30 days after the study treatment periods.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricin 20µg/ml eye drops<br>Lubricin 20µg/ml eye drops 3 times per day | Device: Lubricin 20µg/ml eye drops<br>* Lubricin 20µg/ml eye drops 3 times per day<br>|
| Experimental: Lubricin 50µg/ml eye drops<br>Lubricin 50µg/ml eye drops 3 times per day | Device: Lubricin 50µg/ml eye drops<br>* Lubricin 50µg/ml eye drops 3 times per day<br>|
| Active Comparator: Sodium hyaluronate (HA) 0.18% eye drops<br>Sodium hyaluronate (HA) 0.18% eye drops 3 times per day | Device: Sodium hyaluronate (HA) 0.18% eye drops<br>* Sodium hyaluronate (HA) 0.18% eye drops 3 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability using a Visual analogue scale (VAS) | Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia | Day 1 | 
| Tolerability using a Visual analogue scale (VAS) | Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia | Day 15 | 
| Tolerability using a Visual analogue scale (VAS) | Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia | Day 22 | 
| Treatment-emergent adverse events (TEAEs) |  | Day 1 | 
| Treatment-emergent adverse events (TEAEs) |  | Day 15 | 
| Treatment-emergent adverse events (TEAEs) |  | Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface vital staining with Fluorescein (Oxford scale) |  | Day 1 | 
| Ocular surface vital staining with Fluorescein (Oxford scale) |  | Day 15 | 
| Ocular surface vital staining with Fluorescein (Oxford scale) |  | Day 22 | 
| Schirmer-I test (without anaesthesia) |  | Day 1 | 
| Schirmer-I test (without anaesthesia) |  | Day 15 | 
| Schirmer-I test (without anaesthesia) |  | Day 22 | 
| Permanence of Lubricin on the Ocular Surface |  | Day 1 - 15 minutes - 30 minutes | 
| Permanence of Lubricin on the Ocular Surface |  | Day 15 - 15 minutes - 30 minutes | 
| Permanence of Lubricin on the Ocular Surface |  | Day 22 - 15 minutes - 30 minutes | 
| Tear film break-up time (TFBUT) |  | Day 1 | 
| Tear film break-up time (TFBUT) |  | Day 15 | 
| Tear film break-up time (TFBUT) |  | Day 22 | 
| Best corrected distance visual acuity |  | Day 1 | 
| Best corrected distance visual acuity |  | Day 15 | 
| Best corrected distance visual acuity |  | Day 22 | 
| SANDE questionnaire scores - discomfort improvement entity |  | Day 1 | 
| SANDE questionnaire scores - discomfort improvement entity |  | Day 15 | 
| SANDE questionnaire scores - discomfort improvement entity |  | Day 22 | 
| SANDE questionnaire scores - discomfort improvement speed |  | Day 1 | 
| SANDE questionnaire scores - discomfort improvement speed |  | Day 15 | 
| SANDE questionnaire scores - discomfort improvement speed |  | Day 22 | 
| Signs evaluated by Slit lamp examination (SLE) | blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia | Day 1 | 
| Signs evaluated by Slit lamp examination (SLE) | blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia | Day 15 | 
| Signs evaluated by Slit lamp examination (SLE) | blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia | Day 22 | 
| Intraocular pressure |  | Day 1 | 
| Intraocular pressure |  | Day 15 | 
| Intraocular pressure |  | Day 22 | 
| Corneal sensitivity by Cochet-Bonnet aesthesiometry |  | Day 1 | 
| Corneal sensitivity by Cochet-Bonnet aesthesiometry |  | Day 15 | 
| Corneal sensitivity by Cochet-Bonnet aesthesiometry |  | Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular Discomfort Following Refractive Surgery, Refractive Surgery