A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
1 other identifier
interventional
126
1 country
1
Brief Summary
The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
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
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
September 30, 2020
CompletedSeptember 30, 2020
September 1, 2020
1 month
February 15, 2012
August 21, 2020
September 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
At 1 week follow up
Secondary Outcomes (1)
Symptoms/Complaints
At 1 week follow up
Study Arms (2)
LD118033 contact lens
EXPERIMENTALInvestigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.
PureVision multifocal contact lens
ACTIVE COMPARATORPureVision multifocal low add soft contact lens, to be worn on a daily wear basis.
Interventions
Multifocal contact lens worn on a daily wear basis for 1 week
PureVision multifocal contact lens worn on a daily wear basis for 1 week.
Eligibility Criteria
You may qualify if:
- Have physiologically normal anterior segments.
- Be adapted wearers of soft contact lenses and wear a lens in each eye.
- Be presbyopic and require near add correction in each eye.
- Have no active ocular disease or allergic conjunctivitis.
- Must not be using any topical ocular medications.
You may not qualify if:
- Any Grade 2 or greater finding during the slit lamp examination.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Allergic to any component in the study products.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb Incorporated
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Gerard Cairns, PhD, MCOptom
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 27, 2012
Study Start
January 1, 2012
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
September 30, 2020
Results First Posted
September 30, 2020
Record last verified: 2020-09