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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02193555




Registration number
NCT02193555
Ethics application status
Date submitted
16/07/2014
Date registered
17/07/2014
Date last updated
6/11/2014

Titles & IDs
Public title
Visual Performance of Prototype Contact Lens Designs
Scientific title
Visual Performance of Prototype Contact Lens Designs
Secondary ID [1] 0 0
CRTC2014-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 0 0
Refractive Error 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Etafilcon A, Senofilcon A

Other: Non-presbyopic group - Non-presbyopic group: age ranging from 7 to 39 years

At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.

For each fitting visit, lenses will be fitted bilaterally.

Other: Presbyopic group - Presbyopic group: age 40 and above

At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.

For each fitting visit, lenses will be fitted bilaterally.


Treatment: Devices: Etafilcon A, Senofilcon A
1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual performance
Timepoint [1] 0 0
After about 20 minutes of lens wear
Secondary outcome [1] 0 0
Subjective responses
Timepoint [1] 0 0
After about 40 minutes of 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 7 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.
* Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses.
* Be suitable and willing to wear contact lenses.
Minimum age
7 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.
* Eye surgery within 12 weeks immediately prior to enrolment for this 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.

Study design
Purpose of the study
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?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Brien Holden Vision Institute, Clinical Research Trials Center - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Brien Holden Vision
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens
Trial website
https://clinicaltrials.gov/study/NCT02193555
Trial related presentations / publications
Morgan PB, Efron N. A decade of contact lens prescribing trends in the United Kingdom (1996-2005). Cont Lens Anterior Eye. 2006 May;29(2):59-68. doi: 10.1016/j.clae.2006.02.008. Epub 2006 Mar 31.
Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5.
Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.
Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.
Public notes

Contacts
Principal investigator
Name 0 0
Jiyoon Chung, BOptom
Address 0 0
Brien Holden Vision Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02193555