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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
The packaging used for the comparator in the present investigation aimed at ensuring a complete masking of the test IMD.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18 years of age or older;
- •Patients undergone ocular refractive surgery within 6 months from V1 - Day 1;
- •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.
Outcomes
Primary Outcomes
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS)
Time Frame: 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)
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 ophtalmic assessment at each scheduled visit. Specific ocular symptoms 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 extreme limits of the parameter.
Treatment-emergent Adverse Events (TEAEs) Assessed Throughout the Study
Time Frame: From baseline (Day 1 - pre-dose) to day 22±2
TEAEs included all AEs occurring or worsening after the first dose of IMD. These comprise AEs during the treatment and follow-up period. For TEAE, the number of events was provided. At each visit (Visit 1 which took place at Day 1; Visit 2 which took place at day 15 ± 2; Visit 3, i.e. final visi FU, at Day 22 ± 2/ETV), patients could spontaneously report any physical or medical occurrence and the investigator or designee inquired about the occurrence of TEAEs by asking specific questions. Any untoward (unfavorable \& unintended) change in subject's medical conditions was to be reported as an AE. Changes in any protocol-specific ocular or systemic parameter evaluated during the study were to be reviewed by the investigator. In addition, each patient's response to any questionnaire was to be reviewed by the investigator. Any untoward (unfavorable and unintended) change in a protocol-specific parameter or questionnaire response clinically relevant was to be reported as an AE.
Secondary Outcomes
- Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale)(Day 15±2 (Visit 2); Day 22±2 (Visit 3))
- Change From Baseline in Schirmer-I Test (Without Anaesthesia)(Day 15±2 (Visit 2); Day 22±2 (Visit 3))
- Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT)(Day 15±2 (Visit 2); Day 22±2 (Visit 3))
- Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score(Day 15±2 (Visit 2); Day 22±2 (Visit 3))
- Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores(Day 15±2 (Visit 2); Day 22±2 (Visit 3))
- Change From Baseline in Slit Lamp Examination (SLE) Values(Day 15±2 (Visit 2); Day 22±2 (Visit 3))
- Change From Baseline in IOP (Intraocular Pressure)(Day 15±2 (Visit 2); Day 22±2 (Visit 3))
- Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry(From baseline (Day 1 pre-dose) to Day 15±2 and Day 22±2)