Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
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ClinicalTrials.gov Identifier: NCT00909792 |
Recruitment Status :
Completed
First Posted : May 28, 2009
Results First Posted : October 29, 2010
Last Update Posted : June 29, 2012
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Sponsor:
CIBA VISION
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
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Brief Summary:
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Presbyopia | Device: Lotrafilcon B Device: Senofilcon A | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 259 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |
Arm | Intervention/treatment |
---|---|
Lotrafilcon B / Senofilcon A
Lotrafilcon B, followed by Senofilcon A
|
Device: Lotrafilcon B
Silicone hydrogel, soft, multifocal contact lens Device: Senofilcon A Silicone hydrogel, soft, multifocal contact lens |
Senofilcon A / Lotrafilcon B
Senofilcon A, followed by Lotrafilcon B
|
Device: Lotrafilcon B
Silicone hydrogel, soft, multifocal contact lens Device: Senofilcon A Silicone hydrogel, soft, multifocal contact lens |
Primary Outcome Measures :
- Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: After 1 week of wear ]Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be at least 35 years of age
- Best-corrected distance visual acuity of at least 20/40 in each eye.
- Spectacle add between +0.75D and +1.50D (inclusive).
- Able to be fit in available study sphere powers (-1.00 to -5.00D)
- Currently wearing soft contact lenses at least 5 days a week.
- Other protocol inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks immediately prior to enrollment.
- 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 could be contraindicated as determined by the investigator.
- Astigmatism ≥ 1.00D.
- Currently wearing either of the study products.
- Other protocol inclusion/exclusion criteria may apply.
No Contacts or Locations Provided
Responsible Party: | CIBA VISION |
ClinicalTrials.gov Identifier: | NCT00909792 History of Changes |
Other Study ID Numbers: |
P-319-C-013 |
First Posted: | May 28, 2009 Key Record Dates |
Results First Posted: | October 29, 2010 |
Last Update Posted: | June 29, 2012 |
Last Verified: | January 2012 |
Additional relevant MeSH terms:
Presbyopia Refractive Errors Eye Diseases |