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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Secondary ID [1] 0 0
2012-002238-35
Secondary ID [2] 0 0
11002X-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Disease 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
Timepoint [1] 0 0
Baseline, Day 90
Secondary outcome [1] 0 0
Change From Baseline in Tear Break-up Time (TBUT)
Timepoint [1] 0 0
Baseline, Day 90
Secondary outcome [2] 0 0
Change From Baseline in Corneal Staining
Timepoint [2] 0 0
Baseline, Day 90
Secondary outcome [3] 0 0
Change From Baseline in Conjunctival Staining
Timepoint [3] 0 0
Baseline, Day 90
Secondary outcome [4] 0 0
Change From Baseline in the Schirmer Test
Timepoint [4] 0 0
Baseline, Day 90

Eligibility
Key inclusion criteria
* Have used artificial tears for dry eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
460
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
France
State/province [2] 0 0
Marseille
Country [3] 0 0
France
State/province [3] 0 0
Tours Cedex
Country [4] 0 0
Germany
State/province [4] 0 0
Freiburg
Country [5] 0 0
Italy
State/province [5] 0 0
Padova
Country [6] 0 0
Italy
State/province [6] 0 0
Parma
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Moscow
Country [8] 0 0
Spain
State/province [8] 0 0
Huelva
Country [9] 0 0
Spain
State/province [9] 0 0
Valencia
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Hampshire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Norfolk

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01664949
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01664949