Tolerability, Safety and Efficacy of Lubricin Eye Drops vs Sodium Hyaluronate Eye Drops in Subjects With Mod. Dry Eye
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|ClinicalTrials.gov Identifier: NCT02510235|
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : January 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome Tear Film Insufficiency||Device: Lubricin Device: Sodium Hyaluronate||Not Applicable|
Dry eye, or keratoconjunctivitis sicca, is a chronic inflammatory condition of the ocular surface that may cause severe symptoms and visual impairment. The 2007 international dry eye workshop (DEWS) defined the disease as follows: "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.
In vitro studies have shown that lubricin in saline buffer acts as a lubricant between various surfaces, as well as in synovial fluid, providing evidence that lubricin is a principal lubricating protein in joints. Besides the lubricating property, lubricin has been shown to exert anti-adhesive action, strain energy dissipation, and a protective effect on underlying cells.
Lubricin has been investigated on its roles at the ocular surface, in normal and pathologic conditions such as dry eye. In fact, Lubricin is a natural human protein with most potent lubricant and anti-adhesive properties present on the ocular surface and on meibonian gland. The presence of this protein at the ocular surface was first described by the team of Sullivan D.
Based on the available preclinical lubricin studies may be an important barrier to the development of corneal and conjunctival epitheliopathies in dry eyes and its use as a novel lubricating and anti-adhesive eye drop is under investigation in this clinical investigation. This clinical investigation has been designed to demonstrate that a Lubricin 150 µg/ml eye drop formulation is non-inferior to the currently most-widely used ocular surface lubricant sodium hyaluronate 0.13% in improving signs and symptoms in patients with moderate dry eye.
Up to now, there are no known anticipated adverse events associated with the use of lubricin, anyway the occurrence of side effects cannot be excluded.
It must be considered that topical treatment with lubricin or hyaluronic acid could cause local irritation or allergic reactions. There are no known contraindications to the use of lubricin or hyaluronic acid eye drops. All examinations and assessments that will be carried out during this study are non-invasive, are commonly used in the management of subjects with dry eye and pose no risk to the subjects. There are no known contraindications to the use of lubricin or hyaluronic acid eye drops. No data are available about the embryo and fetal toxicity, therefore the experimental treatment will not be allowed to pregnant women or nursing mothers and women of childbearing potential not using appropriate birth control methods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2015|
Lubricin 150 µg/ml eye drops solution
Lubricin 150 µg/ml eye drops
Active Comparator: Sodium Hyaluronate
Sodium hyaluronate 0.13% eye drops
Device: Sodium Hyaluronate
Sodium hyaluronate 0.13% eye drops
- SANDE [ Time Frame: day 28±4 ]SANDE Questionnaire - TOTAL SCORE
- Ocular Total Tolerability Score [ Time Frame: day 28±4 ]VAS
- Oxford score [ Time Frame: day 28±4 ]Corneal fluorescein surface staining
- Tear Osmolarity [ Time Frame: day 28±4 ]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.
- Schirmer-I Test [ Time Frame: day 28±4 ]Schirmer's test I (without anaesthesia)
- Tear Film Break Up Time [ Time Frame: day 28±4 ]TFBUT
- Best corrected distance visual [ Time Frame: day 28±4 ]BCVA
- Corneal fluorescein surface staining (Oxford score) [ Time Frame: day 28±4 ]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.
- IOP [ Time Frame: day 28±4 ]Intraocular pressure
- TEAE [ Time Frame: day 28±4 ]Adverse Events occurring after the first dose of Device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510235
|Azienda OspedalieroUniversitaria "Policlinico Vittorio Emanuele" Presidio Ospedaliero, Gaspare Rodolico Clinica Oculistica|
|Catania, Italy, 95123|
|Centro Eccellenza Regionale Malattie della Superficie Oculare - Università di Messina|
|Messina, Italy, 98125|
|Principal Investigator:||Caterina Gagliano, MD||Policlinico Vittorio Emanuele, Pres. Osp. G. Rodolico Clinica Oculistica|