Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000204044
Ethics application status
Approved
Date submitted
23/02/2010
Date registered
10/03/2010
Date last updated
12/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Lid Wiper Epitheliopathy: Exploring the links with osmolality and ocular comfort during contact lens wear
Scientific title
A prospective, randomised, double-masked, controlled, cross-over study of the effects of wearing lotrafilcon A versus comfilcom A silicone hydrogel lenses for up to 10 days on lid wiper epitheliopathy in healthy lens wearing participants.
Secondary ID [1] 1477 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lid wiper epitheliopathy 256872 0
Condition category
Condition code
Eye 257023 257023 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to wear either lotrafilcon A silicone hydrogel contact lenses on a daily wear basis for up to 10 days OR comfilcon A silicone hydrogel contact lenses on a daily wear basis flor up to 10 days and then, following a washout period of 7 days where no lenses are worn, crossed over to the other lens group.
Hydrogen peroxide disinfection system (AOSept or Omnicare) will be used for disinfection after each day of wear.
Intervention code [1] 256066 0
Diagnosis / Prognosis
Intervention code [2] 256125 0
Other interventions
Comparator / control treatment
No lens wear during wash out periods of 7 days duration before interventions. The effect of the two interventions will be compared to each other and to the no lens wear condition following the 1 week washout period.
Control group
Active

Outcomes
Primary outcome [1] 257915 0
Lid wiper epitheliopathy grade (o to 3)
Timepoint [1] 257915 0
baseline and after up to 10 days after intervention commencement
Secondary outcome [1] 263397 0
contact lens osmolality (mmol/kg) measured using a vapour pressure osmometer
Timepoint [1] 263397 0
after up to 10 days after intervention commencement
Secondary outcome [2] 263398 0
Ocular comfort rating (1 to 100 scale)
Timepoint [2] 263398 0
baseline and after up to 10 days after intervention commencement

Eligibility
Key inclusion criteria
Ability to wear contact lenses, no contraindications to lens wear, no lens wear in the past 7 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Required use of any ocular eye drops other than unit dose saline rewetting drops during the study period

Study design
Purpose of the study
Diagnosis
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 assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
23/09/2010
Date of last participant enrolment
Anticipated
Actual
30/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256570 0
Self funded/Unfunded
Name [1] 256570 0
Country [1] 256570 0
Funding source category [2] 288254 0
Charities/Societies/Foundations
Name [2] 288254 0
British Contact Lens Association
Country [2] 288254 0
United Kingdom
Primary sponsor type
University
Name
School of Optometry and Vision Science
Address
c/o Dr Isabelle Jalbert
School of Optometry and Vision Science
The University of New South Wales
Entry via Gate 14, Barker Street
Rupert Myers Building (North Wing)
Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 255865 0
None
Name [1] 255865 0
Address [1] 255865 0
Country [1] 255865 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This project aims to deepen our understanding of the causes of discomfort during contact lens wear. Participants will wear two types of contact lenses (lotrafilcon and comfilcon) for up to 10 days at a time.The project hypothesises that there is a link between the saltiness of peoples' tears, of their contact lenses and the presence of superficial damage to the portion of the upper eyelid that wipes over the contact lens and the sensation of discomfort during lens wear.
Trial website
Trial related presentations / publications
1. Stahl U, Delaveris A, Madigan M, Jalbert I. Lid wiper epitheliopathy: exploring the links to comfort and osmolality in contact lens wear. British Contact Lens Association Annual Clinical Conference (BCLA) 2011, Manchester, UK, 2011.
2. Delaveris N, Stahl UG, Madigan M, Jalbert I. Do lissamine green strips from various manufacturers perform equally? Clin Exp Optom 2011;94: 613-614.
Public notes

Contacts
Principal investigator
Name 30875 0
Dr Isabelle Jalbert
Address 30875 0
School of Optometry and Vision Science
The University of New South Wales
Sydney, NSW 2052, Australia
Country 30875 0
Australia
Phone 30875 0
+61-2-9385-9816
Fax 30875 0
Email 30875 0
[email protected]
Contact person for public queries
Name 14122 0
Dr Dr Isabelle Jalbert
Address 14122 0
School of Optometry and Vision Science
The University of New South Wales
Sydney, NSW 2052
Country 14122 0
Australia
Phone 14122 0
+61-2-9385-9816
Fax 14122 0
Email 14122 0
[email protected]
Contact person for scientific queries
Name 5050 0
Dr Dr Isabelle Jalbert
Address 5050 0
School of Optometry and Vision Science
The University of New South Wales
Sydney, NSW 2052
Country 5050 0
Australia
Phone 5050 0
+61-2-9385-9816
Fax 5050 0
Email 5050 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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