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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00762502




Registration number
NCT00762502
Ethics application status
Date submitted
26/09/2008
Date registered
30/09/2008
Date last updated
19/06/2018

Titles & IDs
Public title
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Scientific title
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Secondary ID [1] 0 0
CR-4498
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Astigmatism 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 - senofilcon A toric contact lens
Treatment: Devices - balafilcon A toric contact lens

Active comparator: senofilcon A toric bilaterally - senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Active comparator: balafilcon A toric bilaterally - balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Active comparator: senofilcon A/balafilcon A contralaterally - senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.


Treatment: Devices: senofilcon A toric contact lens
soft contact lens

Treatment: Devices: balafilcon A toric contact lens
soft contact lens
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Corneal Staining
Timepoint [1] 0 0
at 3 months of lens wear (period 1)
Primary outcome [2] 0 0
Limbal Redness
Timepoint [2] 0 0
at 3 months of lens wear (period 1)
Primary outcome [3] 0 0
Bulbar Redness
Timepoint [3] 0 0
at 3 months of lens wear (period 1)
Primary outcome [4] 0 0
Tarsal Roughness
Timepoint [4] 0 0
at 3 months of lens wear (period 1)

Eligibility
Key inclusion criteria
* Able to wear study lenses in parameters available
* Non-presbyopes between the ages of 18-45
* Understand and sign informed consent
* Willing to follow the protocol
* Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
* Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
* Adapted soft contact lens wearer
* Swims no more than once a week
* Has a wearable pair of spectacles.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any ocular or systemic disorder which may contraindicate contact lens wear
* Any topical ocular medication
* Aphakic
* Corneal refractive surgery
* Corneal distortion from hard CL wear or keratoconus
* Pregnant or lactating
* Grade 2 or worse slit lamp signs
* Infectious disease
* Previous clinical study within 2 weeks
* Don't agree to participate
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
* Previous adverse effects that contraindicate extended lens wear.
* Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Study design
Purpose of the study
Other
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
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
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Newtown
Recruitment hospital [2] 0 0
- Camberwell
Recruitment hospital [3] 0 0
- Hawthorn
Recruitment hospital [4] 0 0
- Keilor
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Mitcham
Recruitment hospital [7] 0 0
- Moe
Recruitment postcode(s) [1] 0 0
2042 - Newtown
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
3122 - Hawthorn
Recruitment postcode(s) [4] 0 0
3036 - Keilor
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3132 - Mitcham
Recruitment postcode(s) [7] 0 0
3825 - Moe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00762502