Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens
Lotrafilcon B Multifocal Evaluations - Comparison to a Traditional Multifocal in Higher Spectacle Adds
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
October 29, 2010
CompletedJune 29, 2012
January 1, 2012
1 month
April 10, 2009
September 14, 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 / Omafilcon A
OTHERLotrafilcon B, followed by Omafilcon A
Omafilcon A / Lotrafilcon B
OTHEROmafilcon A, followed by Lotrafilcon B
Interventions
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Hydrogel, soft, multifocal contact lens for daily wear use
Eligibility Criteria
You may qualify if:
- Be at least 35 years of age.
- Best-corrected visual acuity of at least 20/40 in each eye.
- Spectacle add from +1.50D and +2.50D (inclusive).
- Able to be fit in available study sphere powers (Plano to -4.00D).
- Currently wearing soft contact lenses at least 5 days a week.
You may not qualify if:
- Requires concurrent ocular medication.
- 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.
- Previous refractive surgery.
- Astigmatism \> 1.00D.
- Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
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
April 10, 2009
First Posted
April 22, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 29, 2012
Results First Posted
October 29, 2010
Record last verified: 2012-01