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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02553772




Registration number
NCT02553772
Ethics application status
Date submitted
16/09/2015
Date registered
18/09/2015
Date last updated
17/11/2017

Titles & IDs
Public title
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
Scientific title
A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease
Secondary ID [1] 0 0
11182X-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Syndromes 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
Treatment: Drugs - Carboxymethylcellulose Sodium 0.5%

Experimental: OM3 Tear - Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Active comparator: REFRESH OPTIVE® ADVANCED - Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.


Treatment: Drugs: Carboxymethylcellulose Based Eye Drop
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Treatment: Drugs: Carboxymethylcellulose Sodium 0.5%
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 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 the Ocular Surface Disease Index© (OSDI©) Score
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 Score
Timepoint [2] 0 0
Baseline, Day 90
Secondary outcome [3] 0 0
Change From Baseline in Conjunctival Staining Score
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
* Used artificial tears for dry eye
* Visual acuity of at least 20/32 (while wearing glasses, if necessary).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
* Herpes keratitis in the last 6 months
* Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months

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
6/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2016
Sample size
Target
Accrual to date
Final
242
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Optometry & Vision Sciences, The University of Melbourne - Parkville
Recruitment hospital [2] 0 0
Prof. M.T. Coroneo Pty. Ltd. - Randwick
Recruitment hospital [3] 0 0
The University of New South Wales School of Optometry and Vision Science - Sydney
Recruitment postcode(s) [1] 0 0
VIC 3010 - Parkville
Recruitment postcode(s) [2] 0 0
NSW 2031 - Randwick
Recruitment postcode(s) [3] 0 0
NSW 2052 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas

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 new eye drop formulation in patients with dry eye disease.
Trial website
https://clinicaltrials.gov/study/NCT02553772
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/NCT02553772