Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001323718
Ethics application status
Approved
Date submitted
27/11/2013
Date registered
29/11/2013
Date last updated
24/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of lipid supplementation in contact lens wear comfort
Scientific title
Effect of exogenous phospholipid supplementations among habitual soft contact lens wearers in their ocular comfort
Secondary ID [1] 283658 0
None
Universal Trial Number (UTN)
U1111-1150-7806
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular comfort 290609 0
Condition category
Condition code
Eye 290999 290999 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two interventions used.

1. A phospholipid emulsion drop (Systane Balance, Alcon)

2. A phospholipid liposomal spray (Tearsagain, Biorevive)

All participants will use both interventions and placebos during the study period which is 4 separate phases (4 x 14 days). The dose used for drop is 0.05 ml thrice daily for 14 days and for spray is 0.05 ml thrice daily for 14 days. The drop is applied directly to the eye with contact lens wear and the spray is sprayed on to the closed eyelid margins with contact lens wear. To monitor adherence a patient check list will be provided for the participants. The washout period between each treatment is a minimum 48 hours.
Intervention code [1] 288359 0
Treatment: Drugs
Comparator / control treatment
There are two placebos used.

1. A saline drop (Saline contains unpreservative sodium chloride in water 0.9%, (weight/volume))

2. A saline spray

All participants will use both interventions and placebos during the study period which is 4 separate phases (4 x 14 days). The dose used for drop is 0.05 ml thrice daily for 14 days and for spray is 0.05 ml thrice daily for 14 days The drop is applied directly to the eye with contact lens wear and the spray is sprayed on to the closed eyelid margins with contact lens wear. To monitor adherence a patient check list will be provided for the participants. The washout period between each placebo is a minimum 48 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 290981 0
Ocular comfort score of > 32.0 measured using Ocular Comfort Index
Timepoint [1] 290981 0
At baselines and at day 1 and day 14 after the use of intervention/ placebo
Secondary outcome [1] 305734 0
Tear evaporation rate of > 55.6 g/m^2h measured using a modified dermatology instrument named VapoMeter
Timepoint [1] 305734 0
Baseline visits and day 1 and day 14 after the intervention/placebo

Eligibility
Key inclusion criteria
Habitual contact lens wear
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No history of contact lens wear

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomised table created by computer software
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
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated to determine a significant difference of 36 g/m^2h between repeat measurements at the 5% level of significance corrected for multiple comparisons and with 80% power. The within subject standard deviation of 34 g/m^2h used in this calculation was based on a pilot study. The expected difference of 36 g/m^2h was based on the observed change with contact lens wear from the pilot study.

A linear mixed model will be used to compare the clinical, functional and biochemical variables of the contact lens wearers during use of intervention or placebo. Associations between different variables will be assessed using Pearson or Spearman correlation coefficient where appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2013
Actual
2/05/2013
Date of last participant enrolment
Anticipated
30/09/2013
Actual
5/09/2013
Date of last data collection
Anticipated
Actual
31/10/2013
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288339 0
Charities/Societies/Foundations
Name [1] 288339 0
Brien Holden Vision Institute
Country [1] 288339 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5 North Wing, Rupert Myers Building
Gate 14 Barker Street, University of New South Wales
Kensington, NSW, 2033
Country
Australia
Secondary sponsor category [1] 287054 0
None
Name [1] 287054 0
Address [1] 287054 0
Country [1] 287054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290229 0
Human Research Ethics Advisory (HREA), University of New South Wales
Ethics committee address [1] 290229 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 290229 0
Australia
Date submitted for ethics approval [1] 290229 0
06/11/2012
Approval date [1] 290229 0
12/12/2012
Ethics approval number [1] 290229 0
HC12584

Summary
Brief summary
Tear film lipid layer plays an important role in maintaining tear film stability and ocular comfort. Contact lens wear compromises ocular surface equilibrium by disrupting the lipid layer which results in lens related ocular dryness and discomfort. The troublesome symptom of the contact lens wear often leads to discontinuation of lens wear and hence is critical for the researchers to design ways to overcome the challenge. Artificial tear supplements have been used to increase ocular comfort. This study aims to understand tear film lipids of contact lens wearers and also to evaluate the effect of exogenous lipid supplements on different aspects of tear film lipid layer.
Hypotheses:
1. Improved contact lens comfort is associated with a thicker lipid layer and decreased lipid degradation resulting in reduced tear evaporation.
2. Use of an exogenous tear lipid supplement increases lipid thickness, reduces lipid degradation, increases tear stability, reduces tear evaporation and consequently improves contact lens comfort.
Trial website
Trial related presentations / publications
1. Lipid Supplements and Clinical Aspects of Tear Film in Habitual Lens Wearers. Athira Rohit, Mark Willcox, Fiona Stapleton. Optometry and Vision Science, 2017; 94 (2); 174-182.
2. Effects of Lipid Supplements on Tear Biochemistry in Contact Lens Wearers. Athira Rohit, Mark Willcox, Fiona Stapleton. Optometry and Vision Science, 2016; 93 (10); 1203-1209.
1. Lipid supplements & biochemical aspects of tear film in habitual lens wearers. Athira Rohit, Mark Willcox, Fiona Stapleton. Poster presentation at the Association for Research in Vision and Ophthalmology (ARVO), Seattle, US, May 2016.
2. Effect of a lipid emulsion drop in habitual contact lens wearers. Athira Rohit, Mark Willcox, Todd W Mitchell, Fiona Stapleton. Paper presentation at the Association of Research in Vision and Ophthalmology (ARVO), Denver, US, May 2015.
3. Tear film lipids and contact lens comfort. Athira Rohit, Mark Willcox, Fiona Stapleton. Paper presentation at the Ocular Surface Science and Dry Eye conference, Sydney, Australia, July 2014.
4. The effect of lipid supplementations on the tear film lipid layer of habitual soft contact lens wearers; an exploratory study. Athira Rohit, Mark Willcox, Todd Mitchell, Fiona Stapleton. Paper presentation at the Association of Research in Vision and Ophthalmology (ARVO), Orlando, US, May 2014.
Public notes

Contacts
Principal investigator
Name 44582 0
Prof Fiona Stapleton
Address 44582 0
School of Optometry and Vision Science
Level 3 North Wing Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Kensington, NSW, 2033
Country 44582 0
Australia
Phone 44582 0
+ 61 2 9385 5287
Fax 44582 0
Email 44582 0
[email protected]
Contact person for public queries
Name 44583 0
Ms Athira Rohit
Address 44583 0
Level 5 North Wing Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Kensington, NSW, 2033
Country 44583 0
Australia
Phone 44583 0
+61 2 9385 7420
Fax 44583 0
Email 44583 0
[email protected]
Contact person for scientific queries
Name 44584 0
Ms Athira Rohit
Address 44584 0
Level 5 North Wing Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Kensington, NSW, 2033
Country 44584 0
Australia
Phone 44584 0
+61 2 9385 7420
Fax 44584 0
Email 44584 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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