Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000526976
Ethics application status
Approved
Date submitted
23/05/2011
Date registered
23/05/2011
Date last updated
4/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Performance evaluation of cosmetic contact lenses - a useability study
Scientific title
Performance evaluation of cosmetic contact lenses as rated by healthy individuals in a two-week daily wear trial
Secondary ID [1] 262229 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Desire to alter or enhance eye colour 267927 0
Condition category
Condition code
Eye 268068 268068 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
Cosmetic (eye colour-changing) contact lenses worn for a minimum of 4 hours per day for 10 days out of a 14 day period
Intervention code [1] 266621 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266809 0
Ease of handling, assessed by questionnaire
Timepoint [1] 266809 0
Daily until end of observation (14 days)
Primary outcome [2] 266810 0
Comfort, assessed by questionnaire
Timepoint [2] 266810 0
Daily until end of observation (14 days)
Primary outcome [3] 266811 0
Appearance, assessed by questionnaire
Timepoint [3] 266811 0
Daily until end of observation (14 days)
Secondary outcome [1] 276430 0
Visual function, assessed by questionnaire
Timepoint [1] 276430 0
Daily until end of observation (14 days)

Eligibility
Key inclusion criteria
Healthy ocular surface, normal vision
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No history or signs of ocular infection or trauma, no history of ocular surgery, no topical ocular medications

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2011
Actual
15/06/2011
Date of last participant enrolment
Anticipated
Actual
13/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
53
Recruitment outside Australia
Country [1] 3599 0
New Zealand
State/province [1] 3599 0
Auckland

Funding & Sponsors
Funding source category [1] 267119 0
Commercial sector/Industry
Name [1] 267119 0
Vision Science Co. Ltd.
Country [1] 267119 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
Vision Science Co. Ltd.
Address
092-7,
BUKSA-R1,
JAIM-MYEON,
GYEONSAN-S1,
GYEONSANGBUK-DO
Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 264198 0
University
Name [1] 264198 0
Auckland UniServices Limited
Address [1] 264198 0
Level 10, UniServices House,
70 Symonds Street, Auckland

Private Bag, 92019 AMC,
Auckland 1142, New Zealand
Country [1] 264198 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267102 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 267102 0
Research Office
University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [1] 267102 0
New Zealand
Date submitted for ethics approval [1] 267102 0
12/05/2011
Approval date [1] 267102 0
14/06/2011
Ethics approval number [1] 267102 0

Summary
Brief summary
As a measure of potential acceptibility of this product by the NZ market, a performance evaluation study of a cosmetic contact lens, from the lens wearer’s perspective, is being conducted. With the use of questionnaires, the study will evaluate ease of handling during insertion, removal and cleaning, lens comfort, and satisfaction with appearance and visual performance.
Trial website
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 32644 0
A/Prof Jennifer P Craig
Address 32644 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 32644 0
New Zealand
Phone 32644 0
+649 9238173
Fax 32644 0
Email 32644 0
[email protected]
Contact person for public queries
Name 15891 0
A/Prof Jennifer P. Craig
Address 15891 0
Department of Ophthalmology
University of Auckland
Private Bag 92019
Auckland 1142
Country 15891 0
New Zealand
Phone 15891 0
+6499238173
Fax 15891 0
+6493677173
Email 15891 0
[email protected]
Contact person for scientific queries
Name 6819 0
A/Prof Jennifer P. Craig
Address 6819 0
Department of Ophthalmology
University of Auckland
Private Bag 92019
Auckland 1142
Country 6819 0
New Zealand
Phone 6819 0
+6499238173
Fax 6819 0
+6493677173
Email 6819 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.