Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01100411




Registration number
NCT01100411
Ethics application status
Date submitted
7/04/2010
Date registered
9/04/2010
Date last updated
18/07/2012

Titles & IDs
Public title
Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses
Scientific title
Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers
Secondary ID [1] 0 0
M-10-01
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 - Air Optix Aqua
Treatment: Devices - Biofinity
Treatment: Devices - Proclear
Treatment: Devices - Acuvue Oasys
Treatment: Devices - Acuvue 2
Treatment: Devices - Purevision

Active Comparator: Air Optix Aqua - Contact lens material: Lotrafilcon A

Active Comparator: Biofinity - Contact lens material: Comfilcon A

Active Comparator: Proclear - Contact lens material: Omafilcon A

Active Comparator: Acuvue Oasys - Contact lens material: Senofilcon A

Active Comparator: Acuvue 2 - Contact lens material: Etafilcon A

Active Comparator: Purevision - Contact lens material: Balafilcon A


Treatment: Devices: Air Optix Aqua
Contact lens material: Lotrafilcon A

Treatment: Devices: Biofinity
Contact lens material: Comfilcon A

Treatment: Devices: Proclear
Contact lens material: Omafilcon A

Treatment: Devices: Acuvue Oasys
Contact lens material: Senofilcon A

Treatment: Devices: Acuvue 2
Contact lens material: Etafilcon A

Treatment: Devices: Purevision
Contact lens material: Balafilcon A
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lens Geometry
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Corneal Shape
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Conjunctival Staining
Timepoint [2] 0 0
1 week

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;

- 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;

- Has vision correctable to at least 6/12 (20/40) or better at distance in each eye
with contact lenses;

- Be experienced at wearing contact lenses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- • Any pre-existing ocular irritation, injury or condition (including keratoconus and
herpes keratitis) 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

- An active corneal infection or any active ocular disease that would affect
wearing of contact lenses;

- Use of any topical ocular medication during trial with the exception of saline
drops ;

- 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

- Eye surgery within 12 weeks immediately prior to enrolment for this trial;

- Previous corneal refractive surgery;

- Contraindications to contact lens wear;

- Participated or currently enrolled in another clinical trial that may have
affected vision or ocular physiology within the previous 2 weeks;

- Be pregnant (formal testing of pregnancy is not required. A participant's verbal
report is sufficient);

- Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology
lenses 7 calendar days prior.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Institute for Eye Research - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate changes in contact lens geometry after lens wear
Trial website
https://clinicaltrials.gov/ct2/show/NCT01100411
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alcon Call Center
Address 0 0
Alcon Research
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/NCT01100411