A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome

A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With Dry Eye

Sponsoren

Hauptsponsor: Ocusoft, Inc.

Mitarbeiter: ORA, Inc.

Quelle Ocusoft, Inc.
Kurze Zusammenfassung

This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.

Gesamtstatus Completed
Anfangsdatum May 2014
Fertigstellungstermin May 2014
Primäres Abschlussdatum May 2014
Phase Phase 4
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Tear Film Break-Up Time Day 15
Ocular surface damage as measured by fluorescein staining Day 15
Einschreibung 42
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Retaine™

Armgruppenetikett: Arm 1

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Be at least 18 years of age;

- Provide written informed consent;

- Have a reported history of dry eye;

- Have a history of use or desire to use eye drops;

Exclusion Criteria:

- Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;

- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;

- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;

- Have used Restasis® within 30 days of Visit 1;

- Be a woman who is pregnant, nursing or planning a pregnancy;

- Be unwilling to submit a urine pregnancy test if of childbearing potential;

- Have a known allergy and/or sensitivity to the test article or its components;

- Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;

- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Ort
Einrichtung:
Standort Länder

United States

Überprüfungsdatum

June 2014

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: Arm 1

Art: Experimental

Beschreibung: Retain 1-2 drops, bilaterally, BID

Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov