Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
1 other identifier
interventional
259
0 countries
N/A
Brief Summary
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 27, 2009
CompletedFirst Posted
Study publicly available on registry
May 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 29, 2010
CompletedJune 29, 2012
January 1, 2012
1 month
May 27, 2009
September 16, 2010
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
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.
After 1 week of wear
Study Arms (2)
Lotrafilcon B / Senofilcon A
OTHERLotrafilcon B, followed by Senofilcon A
Senofilcon A / Lotrafilcon B
OTHERSenofilcon A, followed by Lotrafilcon B
Interventions
Silicone hydrogel, soft, multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
- Organization
- CIBA VISION
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2009
First Posted
May 28, 2009
Study Start
May 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 29, 2012
Results First Posted
October 29, 2010
Record last verified: 2012-01