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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01444287




Registration number
NCT01444287
Ethics application status
Date submitted
27/09/2011
Date registered
30/09/2011
Date last updated
19/06/2018

Titles & IDs
Public title
Daytime Corneal Swelling During Wear of Narafilcon B Lenses
Scientific title
Secondary ID [1] 0 0
CR-0918 (JKN 0927)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 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 - narafilcon B
Treatment: Devices - Polymacon
Treatment: Devices - Lotrafilcon A
Other interventions - Spectacles

Placebo comparator: Spectacles No Lenses - Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Experimental: narafilcon B - Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Active comparator: polymacon - Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Active comparator: lotrafilcon A - Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.


Treatment: Devices: narafilcon B
test product

Treatment: Devices: Polymacon
marketed product

Treatment: Devices: Lotrafilcon A
marketed product

Other interventions: Spectacles
None - subject used own spectacles
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Corneal Thickness
Timepoint [1] 0 0
After 8 hours of contact lens wear
Primary outcome [2] 0 0
Endothelial Blebs
Timepoint [2] 0 0
baseline, after 20 minutes of treatment conditions
Primary outcome [3] 0 0
Limbal Redness
Timepoint [3] 0 0
Baseline, After 8 hours of treatment conditions
Secondary outcome [1] 0 0
Overall Comfort
Timepoint [1] 0 0
after 8 hours

Eligibility
Key inclusion criteria
* Be of legal age (i.e. = 18 years).
* Be mentally competent, willing and able to sign a written informed consent form.
* Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
* Have spectacle astigmatism <1.25D in each eye.
* Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
* Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Required concurrent ocular medication.
* Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial.

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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Coles-Brennan Pty Ltd - Hawthorn
Recruitment postcode(s) [1] 0 0
- Hawthorn

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Vision Care, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.
Trial website
https://clinicaltrials.gov/study/NCT01444287
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Noel Brennan, McOptom PhD
Address 0 0
Coles-Brennan Pty Ltd
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/NCT01444287