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Trial registered on ANZCTR


Registration number
ACTRN12615000173594
Ethics application status
Approved
Date submitted
1/02/2015
Date registered
23/02/2015
Date last updated
10/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Anti-inflammatory treatments for contact lens discomfort
Scientific title
A proof-of-concept, placebo-controlled clinical trial to compare the efficacy of different formulations of omega-3 essential fatty acid supplements for treating contact lens discomfort
Secondary ID [1] 286083 0
Nil
Universal Trial Number (UTN)
U1111-1166-5926
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens discomfort 294082 0
Condition category
Condition code
Eye 294390 294390 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 (Treatment 1): trigylceride long-chain omega-3 oral supplement for 12 weeks (daily dose range: EPA: 500-1000mg, DHA 250-600mg)
Arm 2 (Treatment 2): triglyceride long-and short-chain omega-3 oral supplement 2 for 12 weeks (daily dose range: EPA: 500-1000mg, DHA 250-600mg, ALA 500-1200mg)
Arm 3 (Treatment 3): topical omega-3 eye drops for 12 weeks (dosed four times daily)
Arm 4: placebo oral supplement for 12 weeks, followed by topical fluorometholone 0.1% eye drops (dosed three times daily) for 2 weeks (as a ‘gold standard’ anti-inflammatory therapy)
Adherence to treatment will be monitored by assessing the return of unused study product at each visit.
Intervention code [1] 291076 0
Treatment: Other
Intervention code [2] 291180 0
Treatment: Drugs
Comparator / control treatment
Arm 4 - Control (Placebo): olive oil oral supplement for 12 weeks (once daily), followed by a two-week treatment with topical fluorometholone 0.1% eye drops
Control group
Placebo

Outcomes
Primary outcome [1] 294179 0
Patient symptoms: contact-lens dry eye questionnaire 8 (CLDEQ-8) survey score, a quantitative and validated survey instrument to grade the severity of contact lens discomfort.
Timepoint [1] 294179 0
Change in CLDEQ-8 score between Days 1 and 84.
Primary outcome [2] 294180 0
Tear osmolarity (tear electrolyte concentration), measured in mOsm/L using the TearLab system.
Timepoint [2] 294180 0
Change in tear osmolarity between Days 1 and 84.
Primary outcome [3] 294181 0
Tear inflammatory cytokine levels using multiplex-CBA analysis techniques.
Timepoint [3] 294181 0
Change in tear cytokine levels between Days 1 and 84.
Secondary outcome [1] 312701 0
Patient symptoms: CLDEQ-8
Timepoint [1] 312701 0
Change from Day 1 to Day 28.
Secondary outcome [2] 312702 0
Tear osmolarity (tear electrolyte concentration), measured in mOsm/L using the TearLab system.
Timepoint [2] 312702 0
Change from Day 1 to Day 28.
Secondary outcome [3] 312703 0
Tear inflammatory cytokine levels using multiplex-CBA analysis techniques.
Timepoint [3] 312703 0
Change from Day 1 to Day 28.
Secondary outcome [4] 312704 0
Additional tear inflammatory cytokine levels and protein levels assayed using multiplex-CBA and mass spectrometry.
Timepoint [4] 312704 0
Change from Day 1 to Days 28 and 84.
Secondary outcome [5] 312705 0
Non-invasive tear break-up time (NITBUT): measure of tear film stability.
Timepoint [5] 312705 0
Change from Day 1 to Days 28 and 84.
Secondary outcome [6] 312706 0
Grading of the extent and confluence of sodium fluorescein staining of the cornea and conjunctiva using the standardised Oxford grading system.
Timepoint [6] 312706 0
Change from Day 1 to Days 28 and 84.
Secondary outcome [7] 312707 0
Grading of the extent and confluence of lissamine green staining of the cornea and conjunctiva using the standardised Oxford grading system.
Timepoint [7] 312707 0
Change from Day 1 to Days 28 and 84.
Secondary outcome [8] 312708 0
Basal tear production: non-stimulated tear production (measured using Schirmer strips with topical anaesthetic).
Timepoint [8] 312708 0
Change from Day 1 to Days 28 and 84.

Eligibility
Key inclusion criteria
Existing contact lens wearers (for at least 6 months), with symptoms of contact lens discomfort (CLDEQ-8 score of at least 13).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-morbid ocular pathology (e.g., ocular infection, intra-ocular inflammation)
Uncontrolled systemic disease
Known or suspected allergy to fish/seafood, nuts, oil or gelatin
Current medication with oral omega-3 supplements
A systemic medical condition where omega-3 supplements are contraindicated (e.g., bleeding disorders, diabetes, atrial fibrillation, familial immunocompromise, adenomatous polyposis, liver disease)

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)
Subject must satisfy all eligibility criteria and provide written informed consent to participate.
Eligible subjects will be enrolled and randomised to one of the four treatment groups (olive oil, omega-3 oral supplement 1, omega-3 oral supplement 2 or topical omega-3 eye drops) using a participant/randomisation number sequence generated in advance that randomly assigns subjects to one of the four groups. This randomisation schedule will be generated by an independent data manager and provided to a separate independent entity responsible for labelling the investigational product.
To preserve masking within the groups taking the oral supplements, the three different types of oral supplements will be packaged in identical containers. Investigators collecting and analysing data will not be involved in the reconciliation of returned study product.
After the 12 week intervention period, subjects allocated to the placebo (olive oil) group will then receive two-weeks of treatment with a ‘gold standard’ anti-inflammatory (topical corticosteroid) for two weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent data manager will generate a simple random number sequence in Microsoft Excel for participant randomisation. The sequence will include equal numbers for the four treatment groups. The code will be kept by the independent data manager and made available for labelling of the investigational product by sequential participant number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To detect a 20% difference in outcome measures treatment and control groups, for 90% power at a confidence level of 95%, the sample size was calculated as 16 participants per group. A total 20 participants will be recruited to compensate for any drop-outs.
Repeated measures analyses of variance (RM-ANOVA) will be performed to assess for treatment effects over time

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290669 0
Commercial sector/Industry
Name [1] 290669 0
CooperVision Pty Ltd
Address [1] 290669 0
5870 Stoneridge Drive, Suite 1 Pleasanton, California 94588
Country [1] 290669 0
United States of America
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Parkville, Victoria, Australia 3010
Country
Australia
Secondary sponsor category [1] 289362 0
None
Name [1] 289362 0
Address [1] 289362 0
Country [1] 289362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292298 0
University of Melbourne Human Research Ethics Committee – Health Sciences sub-committee
Ethics committee address [1] 292298 0
Office for Research Ethics and Integrity, The University of Melbourne, Level 1, 780 Elizabeth Street, Parkville, Victoria Australia 3010
Ethics committee country [1] 292298 0
Australia
Date submitted for ethics approval [1] 292298 0
Approval date [1] 292298 0
12/01/2015
Ethics approval number [1] 292298 0
1443431

Summary
Brief summary
Contact lens discomfort is a multifactorial condition that is “characterised by episodic or persistent adverse ocular sensations related to contact lens wear, which can lead to decreased wearing time and discontinuation.” Currently, the main form of treatment for contact lens discomfort is the use of artificial tears (lubrication drops), which can assist in reducing these symptoms by supplementing the deficient tear fluid. However, as artificial tears fail to address the underlying cause of the condition, for many patients they are inadequate in completely relieving symptoms. New and enhanced therapeutic treatments are therefore needed.

Inflammation has been implicated in the pathogenesis of contact lens discomfort. The aim of this ‘proof-of-concept’, single site clinical trial is to evaluate the benefit of different formulations of omega-3 supplements for treating contact lens discomfort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54542 0
Dr Laura Downie
Address 54542 0
Department of Optometry and Vision Sciences
Level 4 – Alice Hoy Building (Bldg 162), Monash Road
The University of Melbourne
Parkville, Victoria, Australia 3010
Country 54542 0
Australia
Phone 54542 0
+61 3 9035 3043
Fax 54542 0
+61 3 9035 9905
Email 54542 0
ldownie@unimelb.edu.au
Contact person for public queries
Name 54543 0
Dr Laura Downie
Address 54543 0
Department of Optometry and Vision Sciences
Level 4 – Alice Hoy Building (Bldg 162), Monash Road
The University of Melbourne
Parkville, Victoria, Australia 3010
Country 54543 0
Australia
Phone 54543 0
+61 3 9035 3043
Fax 54543 0
Email 54543 0
ldownie@unimelb.edu.au
Contact person for scientific queries
Name 54544 0
Dr Laura Downie
Address 54544 0
Department of Optometry and Vision Sciences
Level 4 – Alice Hoy Building (Bldg 162), Monash Road
The University of Melbourne
Parkville, Victoria, Australia 3010
Country 54544 0
Australia
Phone 54544 0
+61 3 9035 3043
Fax 54544 0
Email 54544 0
ldownie@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary