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Trial registered on ANZCTR


Registration number
ACTRN12618000326291
Ethics application status
Approved
Date submitted
26/02/2018
Date registered
5/03/2018
Date last updated
5/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of ocular signs and symptoms following contact lens wear
Scientific title
Evaluation of ocular signs and symptoms following two hours of contact lens wear of both silicone hydrogel and hydrogel lenses soaked in three multipurpose lens care solutions at three different intervals (1 day, 10 days and 30 days).
Secondary ID [1] 294178 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular signs and symptoms related to contact lens multipurpose solutions and contact lens wear 306786 0
Condition category
Condition code
Eye 305886 305886 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this double masked, contralateral design study, participants will be administered (by a final year optometry student) with hydrogel or silicone hydrogel lenses soaked in either one of the 3 different contact lens care solutions; Biotrue, RevitaLens OcuTec and Opti-free PureMoist. All the contact lens and lens care solutions are available in the Australian market for use. Following soaking for either 1, 10 or 30 days, the lenses will be worn by one eye of the human participants. The other eye will wear a lens of the same material that was soaked in sterile buffered saline solution (control). Both the lenses will look same, neither the participant nor examiner (Stage 5 optometry student under guidance of qualified optometrist) will know which eye is allocated for the control/MPS-soaked lens. The lens allocation will be assigned by a clinical research coordinator. The lens will remain in the participant’s eye for 2 hours, after which visual acuity will be measured and ocular signs and symptoms evaluated using slit lamp biomicroscopy, Oculus Keratograph and Lipiview imaging instruments. Each participant is expected to be evaluated at 9 different visits, for 3 different MPS solutions at 3 different time points of lens-solution soaking with at least 48 hours washout period in between visits. Participants will receive same type of lens for every visit.
Intervention code [1] 300447 0
Early detection / Screening
Intervention code [2] 300475 0
Treatment: Devices
Comparator / control treatment
Control lens will be soaked in sterile buffered saline solution
Control group
Active

Outcomes
Primary outcome [1] 304929 0
To examine changes in the ocular surface after 2 hours wear of a hydrogel (Etafilcon A) and a silicone hydrogel lenses (Comfilcon A) after being soaked in 3 different multipurpose solutions at 1 day, 10 day and 30 day intervals. This will be evaluated using slit lamp biomicroscopy, Oculus Keratograph and Lipiview imaging instruments. Primary outcomes are:
Tear lipid layer thickness: Lipiview imaging instrument
Timepoint [1] 304929 0
Assessed before and after 2 hours of lens wear
Primary outcome [2] 304993 0
Tear film break up time: with corneal fluorescein staining assisted by slit lamp microscopy and OCULUS keratograph
Timepoint [2] 304993 0
Assessed before and after 2 hours of lens wear
Primary outcome [3] 304994 0
Clinical ocular parameters by slit lamp biomicroscopy. Clinical ocular parameters are bulbar redness, limbal redness, and corneal fluorescein staining.
Timepoint [3] 304994 0
Accessed before and after 2 hours of lens wear
Secondary outcome [1] 343634 0
Assessment of visual acuity with a logMAR acuity chart.
Timepoint [1] 343634 0
Assessed before and after 2 hours of lens wear

Eligibility
Key inclusion criteria
18 years or older; male or female
Adequate understanding of English and be able to give informed consent
Person with an ocular refractive prescription
Non-experienced contact lens wearer
Have no ocular history of surgery or injury and no recent or current history of ocular infection.
Prescription range of -1.00 to -8.00 spherical power with 0.25 steps
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would prevent the safe wearing of contact lenses.
Any systemic disease that adversely affects ocular health such as Grave’s disease, epilepsy etc.
Pregnancy or lactating (participant verbal confirmation is sufficient)
An active corneal infection or ocular disease that would prevent wearing contact lenses safely
Any medications (both systemic and ocular) that may alter normal ocular findings (i.e. contribute to ocular dryness) as well as affect the participant’s subjective response to 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)
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 administering the treatment/s

Intervention assignment
Other
Other design features
Test lens in one eye, control lens in the other eye (contralateral)
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/05/2017
Date of last participant enrolment
Anticipated
3/02/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298794 0
University
Name [1] 298794 0
University of New South Wales
Country [1] 298794 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Level 3 School of Optometry and Vision Science RMB North Gate 14 Barker St NSW
2032, Australia
Country
Australia
Secondary sponsor category [1] 297979 0
None
Name [1] 297979 0
Nil
Address [1] 297979 0
Country [1] 297979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299738 0
University of New South Wales
Ethics committee address [1] 299738 0
Ethics Secretariat
UNSW Grants Management Office
Gate 14, Barker Street, Kingsford
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 299738 0
Australia
Date submitted for ethics approval [1] 299738 0
28/03/2017
Approval date [1] 299738 0
02/05/2017
Ethics approval number [1] 299738 0
HC17202

Summary
Brief summary
To evaluate the ocular signs and symptoms following 2 hours of contact lens wear following soaking with 3 commercially available contact lens care multipurpose disinfectant solutions. Two types of lens materials will be used - a hydrogel lens (Etafilcon A) and silicone hydrogel lens (Comfilcon A). Both the dispensing investigators and the contact lens wearers will be masked.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81418 0
Dr Debarun Duttta
Address 81418 0
Level 2, room 2.013A School of Optometry and Vision Science RMB North Gate 14 Barker St Kensington NSW 2032, Australia
Country 81418 0
Australia
Phone 81418 0
+61293854503
Fax 81418 0
Email 81418 0
[email protected]
Contact person for public queries
Name 81419 0
Dr Debarun Duttta
Address 81419 0
Level 2, room 2.013A School of Optometry and Vision Science RMB North Gate 14 Barker St Kensington NSW 2032, Australia
Country 81419 0
Australia
Phone 81419 0
+61293854503
Fax 81419 0
Email 81419 0
[email protected]
Contact person for scientific queries
Name 81420 0
Dr Debarun Duttta
Address 81420 0
Level 2, room 2.013A School of Optometry and Vision Science RMB North Gate 14 Barker St Kensington NSW 2032, Australia
Country 81420 0
Australia
Phone 81420 0
+61293854503
Fax 81420 0
Email 81420 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

Documents added manually
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Documents added automatically
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