Tolerability, Safety and Efficacy of Lubricin Versus Sodium Hyaluronate Eye Drops in Patients Wit… (NCT02507934) | Clinical Trial Compass
CompletedNot Applicable
Tolerability, Safety and Efficacy of Lubricin Versus Sodium Hyaluronate Eye Drops in Patients With Moderate Dry Eye
Italy40 participantsStarted 2015-06-26
Plain-language summary
The objective of this study is to evaluate tolerability, safety and efficacy of Lubricin 150 µg/ml eye drops when compared to a widely used commercial 0.18% sodium hyaluronate eye drop formulation in moderate dry eye patients.
Primary objectives:
* Tolerability using a Visual Analogue Scale (VAS) for foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision, and photophobia;
* Treatment-emergent adverse events (TEAEs), assessed throughout the clinical investigation.
Secondary objectives:
* Corneal fluorescein staining (scored using the Oxford scale);
* Schirmer test type I (without anaesthesia);
* Symptom assessment in dry eye (SANDE);
* Ocular protection index (OPI);
* Tear film break-up time (TFBUT);
* Best corrected distance visual acuity (BCDVA);
* Slit lamp examination (SLE) (Eyelid - Meibomian glands, eyelid erythema, eyelid oedema, lashes, conjunctiva erythema, lens, iris, anterior chamber, corneal transparency, corneal neovascularisation);
* Intraocular pressure (IOP);
* Number of instillations of investigational medical device during the second week of the clinical investigation.
All parameters will be evaluated at Screening visit-V1 (Day -7 up to day -5), baseline visit-V2 (Day 1), V3 (Day 7±1), V4 (Day 14±1) and at Final Visit follow-up-V5 (Day 21±1).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients 18 years of age or older;
✓. Patients with moderate dry eye characterized by at least one eye with signs and symptoms of moderate dry eye (grade 2 or 3 of the 2007 DEWS report);
✓. Patients diagnosed with dry eye from at least 3 months (current use or recommended use of artificial tears for the treatment of Dry Eye);
✓. Average VAS score for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm;
✓. Corneal staining score with fluorescein \> 3 using the Oxford corneal grading system in the worst performing eye;
✓. Schirmer test without anaesthesia ≤ 10 mm/5 minutes in the worst performing eye;
✓. Tear film break-up time (TBUT) ≤ 10 seconds in the worst performing eye;
✓. Best corrected distance visual acuity (BCDVA) score ≥ 0.1 decimal units in both eyes at the time of study enrollment;
Exclusion criteria
What they're measuring
1
Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS)
Timeframe: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
2
Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study.
Timeframe: Visit 5/Final visit/Follow up - Day 21±1
. Patients with a mild Dry Eye condition (severity level 1 according to the Report of the International Dry Eye Workshop -DEWS, 2007);
✕. 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 not related to dry eye 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 (including laser or refractive surgical procedures) in either eye within the 90 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;