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Trial registered on ANZCTR


Registration number
ACTRN12610000907044
Ethics application status
Approved
Date submitted
21/10/2010
Date registered
25/10/2010
Date last updated
27/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective, bilateral, open label study to evaluate the on-eye perfomance of Proclear (registered trademark) 1 Day contact lenses.
Scientific title
Prospective, open-label, daily wear study of Proclear (registered trademark) 1 Day contact lenses to evaluate product performance in both experienced and new contact lens wearers.
Secondary ID [1] 252931 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear performance 258465 0
Condition category
Condition code
Eye 258629 258629 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
performance of commercially available contact lens, Proclear (registered trademark) 1 Day used in daily disposable modality will be evaluated and compared to other daily wear contact lenses. Evaluation of those daily wear contact lenses are from previous studies done in BHVI.
Intervention code [1] 257454 0
Treatment: Devices
Comparator / control treatment
The control will be historic data from previous daily disposable and silicone hydrogel lens studies conducted at the Brien Holden Vision Institute (1985-Now). The historic data include lens fitting and ocular physiological variables collected by examiners and questionnaires completed by participants.
Control group
Historical

Outcomes
Primary outcome [1] 259475 0
To evaluate the on-eye performance of Proclear 1 Day contact lenses. Lens fitting and ocular physiological variables are measured by various optometric equipment such as slit-lamp biomicroscope. Subjective ratings are completed by participants in the form of questionnaires.
Timepoint [1] 259475 0
3 months with 4 visits : Baseline, 2 Week, 1 Month & 3 Month.
Secondary outcome [1] 266058 0
To compare performance of Proclear 1-day to other daily wear contact lenses from historic data via statistical analysis.
Timepoint [1] 266058 0
3 months with 4 visits : Baseline, 2 Week, 1 Month & 3 Month.

Eligibility
Key inclusion criteria
Be able to read, comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Be at least 18 years old;
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;
Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
May be experienced or inexperienced at wearing contact lenses.
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 keratoconus and herpes keratitis) 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 erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
Use of or a need for concurrent category S3 (Pharmacy only) and above ocular medication up to 12 weeks prior to and during the 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 manner or risk of providing a false positive;
N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial;
Eye surgery within 12 weeks immediately prior to enrolment for this trial;
Previous corneal refractive surgery;
Contraindications to contact lens wear;
Known or suspected allergy to ingredients in contact lenses;
Currently enrolled in another clinical trial;
Participation in a clinical trial within the previous 2 weeks or participation in a short-term clinical trial within the previous 48 hours;
Be pregnant* or plan to become pregnant during the trial or is currently breastfeeding.
The Investigator may, at his/her discretion, exclude anyone else 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
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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] 257908 0
Charities/Societies/Foundations
Name [1] 257908 0
Brien Holden Vision Institute
Address [1] 257908 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney, NSW 2052
Country [1] 257908 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, UNSW Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 257103 0
None
Name [1] 257103 0
Address [1] 257103 0
Country [1] 257103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259928 0
VIHEC Human Research Ethics Committee
Ethics committee address [1] 259928 0
Level 4, North Wing, Rupert Myers Building, UNSW, Sydney, NSW 2052
Ethics committee country [1] 259928 0
Australia
Date submitted for ethics approval [1] 259928 0
15/10/2010
Approval date [1] 259928 0
20/10/2011
Ethics approval number [1] 259928 0

Summary
Brief summary
Proclear's Phosphorylcholine (PC Technology TM ) has given Proclear lenses FDA clearance for the claim: “may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms relating to dryness during lens wear.” Such claim was debatable in previous literature.
The purpose of this study is to evaluate clinical performance of Proclear 1-day contact lenses in terms of fitting, physiological and subjective responses. Such that comparison with other daily wear lenses especially new silicone hydrogel lenses can be made.
Trial website
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 31815 0
Address 31815 0
Country 31815 0
Phone 31815 0
Fax 31815 0
Email 31815 0
Contact person for public queries
Name 15062 0
Jennie Diec
Address 15062 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney, NSW 2052
Country 15062 0
Australia
Phone 15062 0
+612 93856230
Fax 15062 0
Email 15062 0
j.diec@brienholdenvision.org
Contact person for scientific queries
Name 5990 0
Jennie Diec
Address 5990 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney, NSW 2052
Country 5990 0
Australia
Phone 5990 0
+612 93856230
Fax 5990 0
+612 93857401
Email 5990 0
j.diec@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