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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Timepoint [1] 0 0
at 3 months of lens wear (period 1)
Primary outcome [2] 0 0
Limbal Redness - Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Timepoint [2] 0 0
at 3 months of lens wear (period 1)
Primary outcome [3] 0 0
Bulbar Redness - Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Timepoint [3] 0 0
at 3 months of lens wear (period 1)
Primary outcome [4] 0 0
Tarsal Roughness - Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
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
Gender
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
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
Accrual to date
Final
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
To evaluate two toric contact lenses on the ocular physiology of existing contact lens
wearers when used in an extended wear modality of days/six nights.
Trial website
https://clinicaltrials.gov/show/NCT00762502
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

Summary results
Other publications