Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01294384
First received: February 10, 2011
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  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
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 ]

Enrollment: 307
Study Start Date: May 2011
Study Completion Date: September 2012
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
One to 2 drops of EDNP-1 instilled to each eye as needed, at least twice daily, for 90 days.
 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
One to 2 drops of EDNP-2 instilled to each eye as needed, at least twice daily for 90 days.
 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
One to 2 drops of carboxymethylcellulose sodium based artificial tear instilled to each eye as needed, at least twice daily for 90 days.
 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

Locations
Australia, New South Wales
Randwick, New South Wales, Australia
Canada, Newfoundland and Labrador
St. Johns, Newfoundland and Labrador, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

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: September 26, 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
Tetrahydrozoline
Carboxymethylcellulose Sodium
Nasal Decongestants
 Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 21, 2013