Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
This study has been completed.
Sponsor:
Abbott Medical Optics
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01024855
First received: December 2, 2009
Last updated: March 1, 2012
Last verified: March 2012
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Purpose
A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
| Condition | Intervention | Phase |
|---|---|---|
|
Myopia Hyperopia Astigmatism |
Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Further study details as provided by Abbott Medical Optics:
Primary Outcome Measures:
- Number of Eyes With No Change in Corneal Staining [ Time Frame: Change from baseline after 1, 2, 4 and 6+ hours of wear ] [ Designated as safety issue: Yes ]Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
| Enrollment: | 30 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RevitaLens OcuTec Multipurpose Solution (Investigational MPS) |
Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
multi-purpose lens care solution
|
| Active Comparator: Opti-Free RepleniSH Multipurpose Solution (MPS, Control) |
Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
multi-purpose lens care solution
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- were at least 18 years old;
- were experienced contact lens wearers;
- were correctable to at least 20/40 or better in both eyes with contact lenses;
- were in good general health, with healthy eyes (other than requiring vision correction);
- had not worn lenses for at least 12 hours before each baseline visit;
- had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
- had previously used an MPS or hydrogen peroxide solution successfully.
Exclusion Criteria:
- had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
- required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
- had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
- were currently participating in any other clinical study;
- had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Abbott Medical Optics |
| ClinicalTrials.gov Identifier: | NCT01024855 History of Changes |
| Other Study ID Numbers: | COBR-106-9608 |
| Study First Received: | December 2, 2009 |
| Results First Received: | April 13, 2011 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Astigmatism Hyperopia Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013