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

Ocular Discomfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031327
• Other study ID #: LUB0116MD
• Status: Completed
• Phase: N/A
• Start date: June 17, 2017
• Est. completion date: August 10, 2017

Study information

• Verified date: July 2018
• Source: Dompé Farmaceutici S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 10, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Discomfort

Intervention

Device:
• Lubricin 20µg/ml eye drops
Lubricin 20µg/ml eye drops 3 times per day
• Lubricin 50µg/ml eye drops
Lubricin 50µg/ml eye drops 3 times per day
• Sodium hyaluronate (HA) 0.18% eye drops
Sodium hyaluronate (HA) 0.18% eye drops 3 times per day

Locations

Country	Name	City	State
Italy	Università La Sapienza- Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Dompé Farmaceutici S.p.A

Country where clinical trial is conducted

Italy, 

Outcome

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