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

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

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).

Study Overview

• Status: Completed
• Conditions: Ocular Discomfort
• Intervention / Treatment: Device: Lubricin 20µg/ml eye drops; Device: Lubricin 50µg/ml eye drops; Device: Sodium hyaluronate (HA) 0.18% eye drops

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Università La Sapienza- Policlinico Umberto I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients 18 years of age or older.
2. Patients undergone ocular refractive surgery within 6 months from Day 1 Visit.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dompé Farmaceutici S.p.A
• Investigators: Principal Investigator: Alessandro Lambiase, MD, PhD, Università La Sapienza- Policlinico Umberto I - Rome

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2017
• Primary Completion (Actual): August 10, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Ocular Discomfort Following Refractive Surgery; Refractive Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid
• Other Study ID Numbers: LUB0116MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No