Evaluation of Lotrafilcon A Lenses Over a Three Month Period
The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period...
Brief Summary
Official Title: “Evaluation of Lotrafilcon A Lenses Over a Three Month Period”
The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.
- Study Type: Interventional
- Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: September 2009
Intervention(s) in this Clinical Trial
- Device: Lotrafilcon A contact lens
- Silicone hydrogel, spherical, soft contact lens
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Lotrafilcon A
Outcome Measures for this Clinical Trial
Primary Measures
- Comfort After Insertion
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: CIBA VISION Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931307
Study ID Number: P-335-C-013
ClinicalTrials.gov Identifier: NCT00931307
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00931307
