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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:
ClinicalTrials.gov Identifier:
NCT01664949
First Posted: August 14, 2012
Last Update Posted: September 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. 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 ]
    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 ]
    Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. 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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01664949     History of Changes
Other Study ID Numbers: 11002X-001
2012-002238-35 ( EudraCT Number )
First Submitted: August 10, 2012
First Posted: August 14, 2012
Results First Submitted: May 22, 2015
Results First Posted: June 8, 2015
Last Update Posted: September 21, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents