Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02484586
Ethics application status
Date submitted
24/06/2015
Date registered
24/06/2015
Date last updated
8/09/2017

Titles & IDs
Public title
Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Scientific title
Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Secondary ID [1] 0 0
CRTC2014-04
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
Treatment: devices - Etafilcon A
Treatment: devices - Nelfilcon A
Treatment: devices - Nesofilcon A
Treatment: devices - Nelfilcon A
Treatment: devices - Etafilcon A
Treatment: devices - Somofilcon A
Treatment: devices - 58% Poly-HEMA
Treatment: devices - Omafilcon A

Other: Presbyope group - 40 years and over with a reading add.
Control lens: Etafilcon A, Nelfilcon A, Nesofilcon A, Somofilcon A, 58% Poly-HEMA
Test lens: Etafilcon A
Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by each participant for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.

Other: Non-Presbyope group - 18-39 years with no reading add.
Control lens: Etafilcon A, Nelfilcon A, Omafilcon A
Test lens: Etafilcon A
Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by participants for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.


Treatment: devices: Etafilcon A
Prototype lens material

Treatment: devices: Etafilcon A
Control lens for presbyope group

Treatment: devices: Nelfilcon A
Control lens for presbyope group

Treatment: devices: Nesofilcon A
Control lens for presbyope group

Treatment: devices: Nelfilcon A
Control lens for non-presbyope group

Treatment: devices: Etafilcon A
Control lens for non-presbyope group

Treatment: devices: Somofilcon A
Control lens for presbyope group

Treatment: devices: 58% Poly-HEMA
Control lens for presbyope group

Treatment: devices: Omafilcon A
Control lens for non-presbyope group

Intervention code [1] 0 0
Treatment: devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale - For each lens, visual acuity will be measured at distance with a computerised LogMAR chart and at near with a near LogMAR chart. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Visual acuity will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit.
Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of visual acuity. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.
Timepoint [1] 0 0
Approximately 1 week after lens fitting
Secondary outcome [1] 0 0
Subjective rating of vision on a 1-10 visual analogue scale - For each lens, subjective ratings of vision will be assessed with a questionnaire based on a 1 to 10 scale in steps of 1. The questionnaire has been designed specifically for this study. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Subjective ratings will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of subjective ratings. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.
Timepoint [1] 0 0
Approximately 1 week after lens fitting

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.

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

- Be suitable and willing to wear contact lenses.
Minimum age
18 Years
Maximum age
70 Years
Gender
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,
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.
Ocular medication can be prescribed during the course of the trial as per standard
optometric practice.

- 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. Note: 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.

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


The people analysing the results/data
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Brien Holden Vision Institute - 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 multiple optimised prototype
soft contact lens designs compared to commercially available contact lenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Sha, BOptom/BSc
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
Contact person responsible for updating information