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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01664949
Registration number
NCT01664949
Ethics application status
Date submitted
10/08/2012
Date registered
14/08/2012
Date last updated
21/09/2015
Titles & IDs
Public title
A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease
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Scientific title
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Secondary ID [1]
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2012-002238-35
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Secondary ID [2]
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11002X-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dry Eye Disease
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Carboxymethylcellulose Based Eye Drop Formulation A
Treatment: Drugs - Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
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.
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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Day 90
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Secondary outcome [1]
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Change From Baseline in Tear Break-up Time (TBUT)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Day 90
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Secondary outcome [2]
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Change From Baseline in Corneal Staining
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Day 90
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Secondary outcome [3]
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Change From Baseline in Conjunctival Staining
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Day 90
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Secondary outcome [4]
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Change From Baseline in the Schirmer Test
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Day 90
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Eligibility
Key inclusion criteria
- Have used artificial tears for dry eye
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2014
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Sample size
Target
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Accrual to date
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Final
460
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Randwick
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment outside Australia
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Belgium
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State/province [1]
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Leuven
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Country [2]
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France
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Marseille
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France
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Tours Cedex
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Germany
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Freiburg
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Italy
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Padova
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Country [6]
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Italy
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State/province [6]
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Parma
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Country [7]
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Russian Federation
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State/province [7]
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Moscow
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Spain
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Huelva
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Spain
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Valencia
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Country [10]
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United Kingdom
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State/province [10]
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Hampshire
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Country [11]
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United Kingdom
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State/province [11]
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Norfolk
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01664949
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01664949
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