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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02214797




Registration number
NCT02214797
Ethics application status
Date submitted
7/08/2014
Date registered
12/08/2014
Date last updated
25/06/2015

Titles & IDs
Public title
Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Scientific title
Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Secondary ID [1] 0 0
ACTRN12614000011684
Secondary ID [2] 0 0
CRTC2013-02
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, Lotrafilcon B , Senofilcon A

Other: Presbyopic group - Low Add - 40 years and over Add of less than +1.50D
Control lens : Lotrafilcon B and Senofilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion. Each lenses will be worn for a week with a minimum 2 day washout period between the lens types. Each lens will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Other: Presbyopic group - Med Add - 40 years and over Add of +1.50D to +1.75D
Control lens : Lotrafilcon B and Senofilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Other: Presbyopic group - High Add - 40 years and over Add of +2.00D to +2.50D
Control lens : Lotrafilcon B and Senofilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Other: Non-presbyopic group - 18 to 39 years old No Add
Control lens : Lotrafilcon B and Etafilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.


Treatment: Devices: Etafilcon A, Lotrafilcon B , Senofilcon A
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in visual performance over 1-week lens wear
Timepoint [1] 0 0
after about 20 minutes of lens wear and after about 1 week of lens wear
Secondary outcome [1] 0 0
Change in subjective response over 1-week of lens wear
Timepoint [1] 0 0
After about 40 mins of lens wear and after 2 days, 4 days and 1 week 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 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

- Correctable to at least 6/12 (20/40) or better in each eye with contact lenses

- Be willing to not wear contact lenses for a minimum of 2 days before each stage of the
clinical trial (after informed consent)
Minimum age
18 Years
Maximum age
70 Years
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 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

- 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 clinical trial products

The Investigator may, at his/her discretion, exclude anyone who they believe may not be
able to fulfil the clinical trial requirements or it is believed to be in the participant's
best interests

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?
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
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Brien Holden Vision Institue, 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 visual performance of prototype soft contact lens designs
compared to commercially available contact lenses over one-week of lens wear.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02214797
Trial related presentations / publications
Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. doi: 10.1046/j.1475-1313.2002.00066.x.
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.
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/ct2/show/NCT02214797