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Trial registered on ANZCTR


Registration number
ACTRN12611000586910
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
7/06/2011
Date last updated
13/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to compare a new contact lens solution with COMPLETE [Registered trade mark] Easy Rub [Registered trade mark] and renu [Registered trade mark] fresh [Trademark], when two commercially available contact lenses are worn in opposite eyes over two and eight hours
Scientific title
A prospective, doubled-masked, cross-over, randomised clinical trial to compare solution induced corneal staining rates between an investigational contact lens care solution, COMPLETE [Registered trade mark] Easy Rub [Registered trade mark] and renu [Registered trade mark] fresh [Trademark] solutions with commercially available contact lenses worn contralaterally over two and eight hours in experienced contact lens wearers
Secondary ID [1] 262325 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 268034 0
Condition category
Condition code
Eye 268163 268163 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, doubled-masked, cross-over, randomised clinical trial where 55 participants will contralaterally wear contact lenses made from balafilcon A and senofilcon A material. The trial will be run in two sequential Parts of three randomised stages each, with each stage corresponding to one solution. All three stages in Part 1 of the trial will utilise plano contact lenses (i.e. contact lenses with no power) while all three stages in Part 2 will utilise power-matched lenses (i.e. contact lenses that have a participant’s power in them). Each stage will have two visits, both of which occur on the same day- dispensing of lenses and assessment after a period of lens wear. The period of wear is for stages in Part 1 will be 2 hours, and in Part 2 the period of wear will be 8 hours. New lenses will be used for each stage. Prior to use for any stage, lenses will be removed from packaging and stored in a standard, flat contact lens case (two wells, one well for each contact lens and capacity of each well approximately 5ml) and soaked overnight in either a PHMB-based new solution or PHMB-based commercially available solutions COMPLETE [Registered trade mark] Easy Rub [Registered trade mark] and renu [Registered trade mark] fresh [Trademark]. For any stage of any Part, solution will only be used to soak lenses overnight and no solution will be given to participants. There are six stages in total (two parts, three stages in each part) with participants to complete all stages. There is a minimum 24 hour wash-out period between stages.
Intervention code [1] 266716 0
Treatment: Devices
Comparator / control treatment
Commercially available solutions will be used as control in both Parts 1 and 2 (4 stages in total). Participants are to complete all six stages in this cross-over study (2 parts, three stages in each part)
Control group
Active

Outcomes
Primary outcome [1] 266905 0
To compare solution induced corneal staining rates of PHMB-based new solution after 2 and 8 hours of lens wear with COMPLETE [Registered trade mark] Easy Rub [Registered trade mark] and renu [Registered trade mark] fresh [Trademark], when used in conjunction with balafilcon A and senofilcon A contact lenses. Solution induced corneal staining is be defined as punctate staining in 4 out of 5 corneal areas.
Timepoint [1] 266905 0
Baseline, 2 hours and 8 hours
Secondary outcome [1] 276598 0
compare ocular comfort of PHMB-based new solution after 2 and 8 hours of lens wear with COMPLETE [Registered trade mark] Easy Rub [Registered trade mark] and renu [Registered trade mark] fresh [Trademark], when used in conjunction with balafilcon A and senofilcon A contact lenses. Ocular comfort will be determined by numeric rating scales.
Timepoint [1] 276598 0
Baseline, 2 hours and 8 hours

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;
-Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
-Be an experienced contact lens wearer;
-Be able to insert and remove contact lenses;
-Be willing to not wear contact lens wear for at least 24 hours before each stage of the clinical trial (after informed consent).
Minimum age
18 Years
Maximum age
No limit
Gender
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 study;
-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 study;
N.B.: Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial and at least 24 hours before study product is used;
-Eye surgery within 12 weeks immediately prior to enrolment for this trial;
-Previous corneal refractive surgery;
-Contraindications to contact lens wear;
-Known allergy or intolerance to ingredients in any of the study 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;
-Pregnancy*;

-The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.
*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

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?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 267199 0
Charities/Societies/Foundations
Name [1] 267199 0
Brien Holden Vision Institute
Address [1] 267199 0
Level 5, Rupert Myers Building Gate 14, Barker Street University of New South Wales, NSW 2052
Country [1] 267199 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Optics, Inc
Address
1700 East St. Andrew Place
PO Box 25162
Santa Ana, CA 92799-5162, USA
Country
United States of America
Secondary sponsor category [1] 266269 0
None
Name [1] 266269 0
Address [1] 266269 0
Country [1] 266269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269191 0
VIHEC Human Research Ethics Committee
Ethics committee address [1] 269191 0
Level 4, North Wing, Rupert Myers Building (RMB), Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Ethics committee country [1] 269191 0
Australia
Date submitted for ethics approval [1] 269191 0
07/06/2011
Approval date [1] 269191 0
21/06/2011
Ethics approval number [1] 269191 0
11/08

Summary
Brief summary
This study will compare solution induced corneal staining rates between three PHMB-based solutions at 2 hours hours and 8 hours, when used with balafilcon A and senofilcon A contact lenses. The hypothesis is there will no difference in solution induced corneal staining rates between the three solutions
Trial website
Trial related presentations / publications
Short-term clinical comparison of two dual-disinfection multipurpose disinfecting solutions
Tilia D, Lazon de la Jara P, Weng R, Naduvilath T, Willcox MD
Eye Contact lens. 2014 Jan; 40(1): 7-11
Public notes

Contacts
Principal investigator
Name 32708 0
Mr Daniel Tilia
Address 32708 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 32708 0
Australia
Phone 32708 0
+61293857516
Fax 32708 0
Email 32708 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 15955 0
Mr Daniel Tilia
Address 15955 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 15955 0
Australia
Phone 15955 0
+61293857516
Fax 15955 0
Email 15955 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 6883 0
Mr Daniel Tilia
Address 6883 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 6883 0
Australia
Phone 6883 0
+61293857516
Fax 6883 0
Email 6883 0
d.tilia@brienholdenvision.org

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