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Trial registered on ANZCTR


Registration number
ACTRN12612000145808
Ethics application status
Approved
Date submitted
31/01/2012
Date registered
1/02/2012
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two commercially-available eye drops on corneal epithelial cell shedding when eye drops are used in one eye for two weeks in healthy participants
Scientific title
A prospective, randomised validation of corneal epithelial cell-counting with two instruments after 4 hours of bilateral contact lens wear and a prospective, randomised, masked, parallel group comparison of two commercially-available tear supplements utilising different preservatives, on corneal epithelial cell shedding when tear supplements are used unilaterally for two weeks
Secondary ID [1] 279830 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Corneal epithelium cell shedding 285716 0
Condition category
Condition code
Eye 285900 285900 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is divided into two stages. Participants can complete just one stage or both stages.
Stage 1: Five participants will undergo a baseline visit and three further scheduled visits (visits 1, 2, and 3). At each visit, visual acuity will be measured and the ocular surface will be assessed.
-Baseline: The corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. This procedure is performed to familiarise the participant to the eye wash procedure.
-Visit 1: Following a 48 hour wash-out (no use of contact lenses or ocular eye drops) participants will have the corneal surface of each eye gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells will be counted using two instruments, the confocal microscopy (manual cell count) and the flow-cytometer (semi-automated cell count), with instrument allocated for each eye by randomisation.
-Visit 2: Following a 48 hour wash-out (no use of contact lenses or ocular eye drops) plano (lens with no power)PureVision [Registered trade mark] contact lenses soaked overnight in renu [Registered trade mark] fresh [Trade mark] solution are inserted bilaterally.
-Visit 3: Lenses are removed four hours after insertion and the corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells will be counted using two instruments, the confocal microscope (manual cell count) and the flow-cytometer (semi-automated cell count), with instrument allocated for each eye by randomisation.
Stage 2: Twenty participants will undergo a baseline visit and two further scheduled visits (visits 1 and 2). At each visit, visual acuity will be measured and the ocular surface will be assessed.
-Baseline: The corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. This procedure is performed to familiarise the participant to the eye wash procedure. If participant has completed stage 1, this procedure is not repeated. Participants are randomly allocated either Revital Eyes [Registered trade mark] (preservative- BAK) or Refresh Tears Plus [Registered trade mark] (preservative-purite), lubricating eye drops. These will be used four times per day for two weeks unilaterally (in one eye only), with the eye designated for eye drop use randomly allocated.
-Visit 1: After 7 days of unilateral eye drop use, the corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells for eye will be counted using flow-cytometry.
-Visit 2: After 14 days of unilateral eye drop use, the corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells for eye will be counted using flow-cytometry.
Intervention code [1] 284155 0
Treatment: Other
Comparator / control treatment
Stage 1: The manual method of cell counting will be the control. Comparisons will be made between the two instruments.

Stage 2: The number of cells shed in the eye not using lubricating eye drops will be the control. Comparisons will be made for each eye drop between the control and also between eye drops.
Control group
Active

Outcomes
Primary outcome [1] 286394 0
To determine if there is a difference in corneal epithelial cell shedding between eyes exposed to tear-supplements preserved with either BAK or Purite. Epithelial cells shed in the retained solution from the ocular saline wash will be passed through the Attune Acoustic focussing Flow cytometer and cells will be counted using Attune Flow cytometer software
Timepoint [1] 286394 0
After 7 and 14 days of lubricating eye drop use
Secondary outcome [1] 295773 0
To validate the flow-cytometer as a method of counting collected human corneal epithelial cells
Timepoint [1] 295773 0
After 4 hours of contact lens wear

Eligibility
Key inclusion criteria
-Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
-Be at least 18 years old, male or female.
-Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
-Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses.
-Be an experienced contact lens wearer (but willing to not wear contact lenses for the duration of the trial, except, during stage visits 2-3) or a non lens wearer (but willing to wear plano lenses for approximately four hours on one day during stage 1 visits 2-3).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
-Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
-Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
-Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
-Eye surgery within 12 weeks immediately prior to enrolment for this trial.
-Previous corneal refractive surgery.
-Known allergy or intolerance to ingredients in any of the clinical trial products.
-Currently enrolled in another clinical trial.
-Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
-Not willing to not wear contact lenses for the duration of the clinical trial.
-Pregnancy* (either at enrolment or during the course of the trial). Formal testing of pregnancy is not required. A participant’s verbal report is sufficient
-The Investigator may, at his / her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.

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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
28/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284605 0
Charities/Societies/Foundations
Name [1] 284605 0
Brien Holden Vision Institute
Country [1] 284605 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Allergan, Inc
Address
2525 Dupont Drive, Irvine,
CA 92612-1599
Country
United States of America
Secondary sponsor category [1] 283525 0
None
Name [1] 283525 0
Address [1] 283525 0
Country [1] 283525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286600 0
Ethics committee address [1] 286600 0
Ethics committee country [1] 286600 0
Date submitted for ethics approval [1] 286600 0
01/02/2012
Approval date [1] 286600 0
Ethics approval number [1] 286600 0

Summary
Brief summary
this trial will investigate the effect of preservatives in comfort eye-drops on corneal epithelial cells
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33704 0
Address 33704 0
Country 33704 0
Phone 33704 0
Fax 33704 0
Email 33704 0
Contact person for public queries
Name 16951 0
Daniel Tilia
Address 16951 0
Level 5, North Wing, RMB, Gate 14, Barker
Street,
The University of New South Wales
SYDNEY NSW 2052
Country 16951 0
Australia
Phone 16951 0
+612 9385 6165
Fax 16951 0
Email 16951 0
[email protected]
Contact person for scientific queries
Name 7879 0
Daniel Tilia
Address 7879 0
Level 5, North Wing, RMB, Gate 14, Barker
Street,
The University of New South Wales
SYDNEY NSW 2052
Country 7879 0
Australia
Phone 7879 0
+612 9385 6165
Fax 7879 0
Email 7879 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.