A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01664949
First received: August 10, 2012
Last updated: May 22, 2015
Last verified: May 2015
  Purpose

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.


Condition Intervention Phase
Dry Eye Disease
Drug: Carboxymethylcellulose Based Eye Drop Formulation A
Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.


Secondary Outcome Measures:
  • Change From Baseline in Tear Break-up Time (TBUT) [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.

  • Change From Baseline in Corneal Staining [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.

  • Change From Baseline in Conjunctival Staining [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.

  • Change From Baseline in the Schirmer Test [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.


Enrollment: 460
Study Start Date: January 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
Drug: Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
Active Comparator: OPTIVE™
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
Other Names:
  • REFRESH OPTIVE™
  • OPTAVA™

  Eligibility

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

Inclusion Criteria:

  • Have used artificial tears for dry eye

Exclusion Criteria:

  • Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
  • History of eye surgery or trauma in the 6 months prior to study start
  • Current use or use within 2 weeks of study start, of topical eye medications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664949

Locations
Australia, New South Wales
Randwick, New South Wales, Australia
Belgium
Leuven, Belgium
France
Marseille, France
Tours Cedex, France
Germany
Freiburg, Germany
Italy
Padova, Italy
Parma, Italy
Russian Federation
Moscow, Russian Federation
Spain
Huelva, Spain
Valencia, Spain
United Kingdom
Southampton, Hampshire, United Kingdom
Great Yarmouth, Norfolk, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01664949     History of Changes
Other Study ID Numbers: 11002X-001, 2012-002238-35
Study First Received: August 10, 2012
Results First Received: May 22, 2015
Last Updated: May 22, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Eye Diseases
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Tetrahydrozoline
Autonomic Agents
Cardiovascular Agents
Gastrointestinal Agents
Laxatives
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on August 26, 2015