Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000154808
Ethics application status
Approved
Date submitted
1/02/2012
Date registered
3/02/2012
Date last updated
15/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of ocular health and comfort in non spectacle wearer and non contact lens wearers (emmetropes) for three months
Scientific title
Prospective, single group clinical trial where a minimum of 40 participants (non spectacle and non contact lens wearers) will be assessed for a total of three months, for ocular surface characteristics and subjective responses such as comfort
Secondary ID [1] 279846 0
Nil
Universal Trial Number (UTN)
U1111-1127-6579
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular health 285733 0
Ocular comfort/discomfort 285734 0
Condition category
Condition code
Eye 285915 285915 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ocular health (by visual acuity measurements, autorefraction/subjective refraction, slitlamp examination of the anterior eye) and comfort (by subjective comfort questionnaires) of non spectacle and non contact lens wearers are assessed at the baseline, 2 hours, 2 weeks, 1 month and 3 months after the baseline over the course of the trial. The number of recruited participants may change to ensure the drop out number does not reduce the sample size to a level below what is required for the demonstration of statistical power and significance.
Intervention code [1] 284168 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286409 0
Ocular health by assessing ocular redness, corneal and conjunctival fluorescein staining using slitlamp examination of the anterior eye
Timepoint [1] 286409 0
Measured at Baseline, 2 Weeks after Baseline, 1 Month after Baseline and 3 Months after Baseline. It may also be measured at any unscheduled visits during the trial.
Primary outcome [2] 286410 0
Subjective comfort ratings measured with a Numeric Rating Scale of 1 to 10.
Timepoint [2] 286410 0
Measured at Baseline, 2 Weeks after Baseline, 1 Month after Baseline and 3 Months after Baseline. It may also be measured at any unscheduled visits during the trial.
Secondary outcome [1] 295802 0
Nil
Timepoint [1] 295802 0
Nil

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 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 participating.
Have a ocular prescription between +/- 0.50D (inclusive), ie no need for correction
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.
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens 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
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Currently enrolled in another clinical trial.
Participation in a clinical trial within the previous 2 weeks
Pregnancy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284615 0
Charities/Societies/Foundations
Name [1] 284615 0
Brien Holden Vision Institute
Country [1] 284615 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5 North Wing Rupert Myers Buidling, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 283533 0
None
Name [1] 283533 0
Address [1] 283533 0
Country [1] 283533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286607 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 286607 0
Ethics committee country [1] 286607 0
Australia
Date submitted for ethics approval [1] 286607 0
05/01/2012
Approval date [1] 286607 0
27/01/2012
Ethics approval number [1] 286607 0
2011-12-586

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33715 0
Address 33715 0
Country 33715 0
Phone 33715 0
Fax 33715 0
Email 33715 0
Contact person for public queries
Name 16962 0
Jennie Diec
Address 16962 0
Level 5, North Wing Rupert Myers Building, Gate 14, Barker Street UNSW Sydney NSW 2052
Country 16962 0
Australia
Phone 16962 0
+61 2 9385 7516
Fax 16962 0
+61 2 9385 7401
Email 16962 0
j.diec@brienholdenvision.org
Contact person for scientific queries
Name 7890 0
Jennie Diec
Address 7890 0
Level 5, North Wing Rupert Myers Building, Gate 14, Barker Street UNSW Sydney NSW 2052
Country 7890 0
Australia
Phone 7890 0
+61 2 9385 7516
Fax 7890 0
+61 2 9385 7401
Email 7890 0
j.diec@brienholdenvision.org

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.