In-vivo Wettability Grading and Assessment Study (CIAN)
This study has been completed.
Sponsor:
CIBA VISION
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01010555
First received: November 9, 2009
Last updated: June 26, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: lotrafilcon B Device: balafilcon A Device: senofilcon A Device: enfilcon A |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- On-eye Wettability [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ]On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.
| Enrollment: | 25 |
| Study Start Date: | October 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: lotrafilcon B
Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
|
Device: lotrafilcon B
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Air Optix
|
|
Active Comparator: balafilcon A
Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
|
Device: balafilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: PureVision
|
|
Active Comparator: senofilcon A
Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
|
Device: senofilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Acuvue OASYS
|
|
Active Comparator: enfilcon A
Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
|
Device: enfilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Avaira
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- is at least 17 years of age
- has read and signed an information consent letter
- is a current daily wear contact lens wearer
- has acceptable fit with the study lenses
- has had an ocular exam in the last two years
- other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- has any ocular disease
- has undergone corneal refractive surgery or is aphakic
- has any systemic disease affecting ocular health
- is pregnant or lactating
- other protocol-defined exclusion criteria may apply
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010555
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010555
Locations
| Canada, Ontario | |
| Centre for Contact Lens Research: University of Waterloo | |
| Waterloo, Ontario, Canada, N2L 3G1 | |
Sponsors and Collaborators
CIBA VISION
University of Waterloo
More Information
No publications provided
| Responsible Party: | Alcon Research ( CIBA VISION ) |
| ClinicalTrials.gov Identifier: | NCT01010555 History of Changes |
| Other Study ID Numbers: | P-368-C-104 |
| Study First Received: | November 9, 2009 |
| Results First Received: | May 3, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
ClinicalTrials.gov processed this record on March 03, 2015