Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye

Status Completed

Clinical Trial Summary

The study evaluates the safety, ocular tolerability and efficacy of emulsion eye drops with sacha inchi seed oil, trehalose and hyaluronic acid in the treatment of moderate or severe dry eye in adult patients. The investigative device is studied in comparison with control eye drops containing hyaluronic acid for up to 30 days.

Clinical Trial Description

According to the current view on dry eye disease, tear film instability, tear film hyperosmolarity, and ocular surface inflammation and damage are identified as etiological factors. The first-line medicinal management options include ocular lubricants such as eye drops and sprays. Emulsion eye drops are a relatively recent entity among topical therapies with an intention to account for deficiencies in the outermost lipid layer of the tear film.

Piiloset Trehalose Emulsion Eye Drops was developed to target and restore the three main layers (mucin, aqueous, and lipid) of the tear film and to counteract the key etiological factors leading to dry eye. Hyaluronic acid and the oil component are intended to restore tear film instability, the hypo-osmolar composition and trehalose as an osmoprotectant are intended to protect the ocular epithelium against hyperosmolarity, and ocular surface inflammation and cellular damage are prevented by the cytoprotective and/or anti-oxidative action of hyaluronic acid, trehalose, and sacha inchi oil components. Additional water binding in the tear film is provided by hyaluronic acid, trehalose, and glycerol. Lubricating the ocular surface by high-molecular-weight hyaluronic acid will extend the precorneal retention time. Adjustments made to certain physical and chemical parameters in the formulation are anticipated to improve tear film spreading and adhesion. The optically clear o/w emulsion formulation is free of preservatives, materials of animal origin, phosphates, or alcohol. The combined action of the individual components is expected to produce clinically relevant mitigation of the signs and symptoms of dry eye.

The study comprises three Parts with scheduled visits on Day 1 (all Parts) and on end-of-study date (Parts 2 and 3) to the study centre. Each study subject will participate in no more than one Part of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03569202
Study type	Interventional
Source	Kuopio University Hospital
Contact
Status	Completed
Phase	N/A
Start date	May 21, 2018
Completion date	November 8, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02522312` - A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients	N/A
Completed	`NCT02597803` - Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1	Phase 2/Phase 3
Completed	`NCT01863368` - Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining	N/A
Completed	`NCT01753752` - Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation	Phase 2
Completed	`NCT01753687` - Correlation of Different Signs for Assessment of Dry Eye Syndrome	N/A
Completed	`NCT01212471` - A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease	Phase 3
Completed	`NCT01198782` - Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%	Phase 4
Completed	`NCT01162954` - Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers	Phase 1
Completed	`NCT00544713` - Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery	N/A
Completed	`NCT00535054` - Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms	N/A
Completed	`NCT00344721` - A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome	N/A
Completed	`NCT03830359` - Efficacy, Safety of T2769 in Dry Eye Disease	N/A
Completed	`NCT04139122` - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease	Phase 1/Phase 2
Completed	`NCT02758327` - Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops	Phase 4
Completed	`NCT02066051` - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD	N/A
Completed	`NCT01970917` - Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects	Phase 4
Completed	`NCT02092207` - Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT01541891` - Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT01252121` - Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline	N/A
Completed	`NCT00765804` - Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye	Phase 2