Feasibility of a New Silicone Hydrogel Lens
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens
1 other identifier
interventional
120
1 country
1
Brief Summary
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
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 May 2010
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
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
April 30, 2014
CompletedApril 30, 2014
March 1, 2014
1 month
May 25, 2010
March 28, 2014
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
7 days
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
7 days
Secondary Outcomes (2)
Lens Wettability, Test Lens vs. Acuvue Oasys
7 days
Lens Wettability, Test Lens vs. Air Optix Aqua
7 days
Study Arms (3)
Investigational contact lens
EXPERIMENTALBausch \& Lomb
Acuvue Oasys Contact Lens
ACTIVE COMPARATORJohnson \& Johnson Lens
Air Optix Aqua
ACTIVE COMPARATORCiba Vision
Interventions
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
Eligibility Criteria
You may qualify if:
- Participants must have clear central corneas and be free of any anterior segment disorders.
- Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.
You may not qualify if:
- Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Participants with any systemic disease affecting ocular health.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants with an active ocular disease or are using any ocular medication.
- Participants who have had any corneal surgery (eg, refractive surgery).
- Participants who are allergic to any component in the study care products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Steffen
- Organization
- Bausch + Lomb
Study Officials
- STUDY DIRECTOR
Gerard Carains, MCOptom, PhD
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
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 26, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
April 30, 2014
Results First Posted
April 30, 2014
Record last verified: 2014-03