Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.

NCT ID: NCT03031327

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-17
• Study Completion Date: 2017-08-10

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.

Conditions

Ocular Discomfort

Keywords

Ocular Discomfort Following Refractive Surgery; Refractive Surgery; sodium hyaluronate; HA; Vismed®; Lubricin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lubricin 20µg/ml

Lubricin 20µg/ml eye drops solution

Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2.

All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye".

The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable.

After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2.

Group Type: EXPERIMENTAL

Lubricin 20µg/ml

Intervention Type: DEVICE

Lubricin 20µg/ml eye drops

Lubricin 50µg/ml

Lubricin 50µg/ml eye drops solution

Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2.

All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye".

The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable.

After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2.

Group Type: EXPERIMENTAL

Lubricin 50µg/ml

Intervention Type: DEVICE

Lubricin 50µg/ml eye drops

Sodium hyaluronate

Vismed® 0.18% Sodium hyaluronate (HA) eye drops

Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2.

All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye".

The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable.

After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2.

Group Type: ACTIVE_COMPARATOR

Sodium hyaluronate 0.18%

Intervention Type: DEVICE

Sodium hyaluronate (HA) 0.18% eye drops

Interventions

Lubricin 20µg/ml

Lubricin 20µg/ml eye drops

Intervention Type: DEVICE

Lubricin 50µg/ml

Lubricin 50µg/ml eye drops

Intervention Type: DEVICE

Sodium hyaluronate 0.18%

Sodium hyaluronate (HA) 0.18% eye drops

Intervention Type: DEVICE

Other Intervention Names

Vismed®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dompé Farmaceutici S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavio Mantelli, MD-PhD

Role: STUDY_DIRECTOR

Dompé Farmaceutici S.p.A

Locations

Dipartimento "Organi di senso" Università La Sapienza- Policlinico Umberto I

Rome, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIV-15-05-013553

Identifier Type: OTHER

Identifier Source: secondary_id

LUB0116MD

Identifier Type: -

Identifier Source: org_study_id