Clinical Performance Comparison of Two Contact Lenses
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|ClinicalTrials.gov Identifier: NCT00975585|
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : March 22, 2011
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment|
|Myopia||Device: senofilcon A Device: lotrafilcon B|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||379 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses|
|Actual Study Start Date :||August 1, 2009|
|Primary Completion Date :||October 1, 2009|
|Study Completion Date :||October 1, 2009|
Active Comparator: senofilcon A both eyes
soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.
Device: senofilcon A
soft contact lens, 2-week replacement indicated
Active Comparator: lotrafilcon B both eyes
soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen
Device: lotrafilcon B
soft contact lens with a 4-week replacement indicated.
- Average Corneal Staining [ Time Frame: 2 weeks ]The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
- Visual Acuity [ Time Frame: 2 weeks ]Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
- Overall Comfort [ Time Frame: 2 weeks ]After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
- Overall Comfort [ Time Frame: 2 weeks and 4 weeks ]After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
- Limbal Redness [ Time Frame: 2 weeks ]The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
- Bulbar Redness [ Time Frame: 2 weeks ]The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
- Symptoms of Dryness [ Time Frame: 2 weeks ]Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975585
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|Study Director:||Sheila , B Hickson-Curran, BSc, MCOptom||Johnson & Johnson Vision Care, Inc.|