Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01294384

Purpose

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: Formulation 1: Eye Drops New Platform (EDNP) - 1 Drug: Formulation 2: EDNP - 2 Drug: carboxymethylcellulose sodium based artificial tear	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Tetrahydrozoline hydrochloride Carboxymethylcellulose Sodium Hydroxypropyl methylcellulose

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from Baseline in Ocular Surface Disease Index© (OSDI) Score [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:	297
Study Start Date:	May 2011
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Formulation 1: Eye Drops New Platform (EDNP) - 1 Formulation 1: Eye Drops New Platform (EDNP) - 1	Drug: Formulation 1: Eye Drops New Platform (EDNP) - 1 One to 2 drops of EDNP-1 instilled to each eye as needed, at least twice daily, for 90 days.
Experimental: Formulation 2: EDNP - 2 Formulation 2: EDNP - 2	Drug: Formulation 2: EDNP - 2 One to 2 drops of EDNP-2 instilled to each eye as needed, at least twice daily for 90 days
Active Comparator: carboxymethylcellulose sodium based artificial tear carboxymethylcellulose sodium based artificial tear	Drug: carboxymethylcellulose sodium based artificial tear One to 2 drops of carboxymethylcellulose sodium based artificial tear instilled to each eye as needed, at least twice daily for 90 days Other Name: Refresh Tears®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Current use of an artificial tear product at least twice daily for at least 3 months, on average
Ability/agreement to continue wearing existing spectacle correction (glasses) during study

Exclusion Criteria:

Anticipated contact lens wear during study or contact lens use within 6 months
Active ocular infection or allergy
Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
Use of any topical cyclosporine products within 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294384

Contacts

Contact: Allergan Inc.

clinicaltrials@allergan.com

Locations

Australia, New South Wales
	Recruiting
Randwick, New South Wales, Australia
Canada, Newfoundland and Labrador
	Recruiting
St. Johns, Newfoundland and Labrador, Canada

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

More Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01294384 History of Changes
Other Study ID Numbers:	10078X-001
Study First Received:	February 10, 2011
Last Updated:	May 14, 2012
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Tetrahydrozoline
Laxatives

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012