Dry Eye Syndrome Clinical Trial
Official title:
A Randomized, Double-masked, Controlled, Non-inferiority Study to Evaluate Tolerability, Safety and Efficacy of Lubricin Eye Drops vs Sodium Hyaluronate Eye Drops Given 4 Times a Day for 4 Weeks & 1 Week Follow-up in Subjects With Dry Eye
NCT number | NCT02510235 |
Other study ID # | LUB0114MD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | June 2015 |
Verified date | July 2015 |
Source | Dompé Farmaceutici S.p.A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms
of discomfort, visual disturbance, and tear film instability with potential damage to the
ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation
of the ocular surface.
Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted
product of cells that line the joint tissues, which is present at the surface of articular
cartilage and it has been investigated on its roles at the ocular surface, in normal and
pathologic conditions such as dry eye.
The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye
drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution
in subjects with moderate dry eye.
Status | Completed |
Enrollment | 56 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: To be checked at the screening visit (V1) from day -14 to day -8 days before run-in period and confirmed at baseline visit (V2): 1. Subjects 18 years of age or older. 2. Subjects with moderate dry eye characterized by tear film osmolarity > 312 mOsm 3. Subjects with both VAS for frequency and severity of symptoms, SANDE items, at screening & baseline > 25 mm (SANDE overall score > 25 mm). 4. Subjects 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) 5. Subjects diagnosed with dry eye from at least 6 months (current use or recommended use of artificial tears/lubricants for the treatment of Dry Eye) 6. Best corrected distance visual acuity (BCDVA) score of = 0.1 decimal units in both eyes at the time of study enrolment. 7. The Informed Consent by approved Ethics Committees should be signed by the subject before any study procedures. Exclusion Criteria: 1. Evidence of an active ocular infection in either eye 2. History or presence of ocular surface disorders not related to dry eye in either eye 3. History or evidence of eyelid abnormality in either eye 4. 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 5. 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 6. Presence or history of any ocular or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trail procedures (e.g. ocular trauma, progressive or degenerative corneal conditions, uveitis, systemic vasculitis, collagen vascular diseases, poorly controlled diabetes, autoimmune disease, systemic infection.) 7. Known hypersensitivity to one of the components of the study or procedural medications 8. Participation in another clinical study at the same time as the present study or within 90 days of baseline visit 9. History of drug, medication or alcohol abuse or addiction. 10. 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 during the entire course of and 30 days after the study treatment periods. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda OspedalieroUniversitaria "Policlinico Vittorio Emanuele" Presidio Ospedaliero, Gaspare Rodolico Clinica Oculistica | Catania | |
Italy | Centro Eccellenza Regionale Malattie della Superficie Oculare - Università di Messina | Messina |
Lead Sponsor | Collaborator |
---|---|
Dompé Farmaceutici S.p.A |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SANDE | SANDE Questionnaire - TOTAL SCORE | day 28±4 | |
Secondary | Ocular Total Tolerability Score | VAS | day 28±4 | |
Secondary | Oxford score | Corneal fluorescein surface staining | day 28±4 | |
Secondary | Tear Osmolarity | Tear osmolarity is an important indicator of the eye surface health. <300 mOsm/L: normal; 300 < mOsm/L< 320: mild instability of the tear film; 320 < mOsm/L< 340: moderate; <340: severe. | day 28±4 | |
Secondary | Schirmer-I Test | Schirmer's test I (without anaesthesia) | day 28±4 | |
Secondary | Tear Film Break Up Time | TFBUT | day 28±4 | |
Secondary | Best corrected distance visual | BCVA | day 28±4 | |
Secondary | Corneal fluorescein surface staining (Oxford score) | The Oxford score divides corneal staining into six groups according to severity from 0 (absent) to 5 (severe). The examiner compares the overall appearance of the patient's corneal staining with a reference figure, simulating the pattern of staining encountered in dry eye disease. | day 28±4 | |
Secondary | IOP | Intraocular pressure | day 28±4 | |
Secondary | TEAE | Adverse Events occurring after the first dose of Device | day 28±4 |
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