Evaluation of Lotrafilcon A Lenses Over a Three Month Period
This study has been completed.
Sponsor:
CIBA VISION
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00931307
First received: July 1, 2009
Last updated: June 26, 2012
Last verified: October 2010
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Purpose
The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: Lotrafilcon A contact lens |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Lotrafilcon A Lenses Over a Three Month Period |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Comfort After Insertion [ Time Frame: 3 months ] [ Designated as safety issue: No ]Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
| Enrollment: | 22 |
| Study Start Date: | May 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lotrafilcon A |
Device: Lotrafilcon A contact lens
Silicone hydrogel, spherical, soft contact lens
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- On examination, have ocular findings considered to be "normal" and which would not prevent a subject from safely wearing contact lenses.
- Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
- Be able to wear the study lenses in the available powers.
- Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
- Other protocol inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
- History of corneal refractive surgery.
- Other protocol inclusion/exclusion criteria may apply.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research ( CIBA VISION ) |
| ClinicalTrials.gov Identifier: | NCT00931307 History of Changes |
| Other Study ID Numbers: | P-335-C-013 |
| Study First Received: | July 1, 2009 |
| Results First Received: | September 16, 2010 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013