Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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