Clinical Performance Comparison of Several Different Contact Lenses
Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses
1 other identifier
interventional
71
1 country
11
Brief Summary
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel 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 2009
Shorter than P25 for not_applicable
11 active sites
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
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
April 28, 2014
CompletedJune 19, 2018
August 1, 2017
9 months
May 29, 2009
March 27, 2014
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
Limbal Hyperemia (Redness)
Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
2 weeks
Limbal Hyperemia (Redness)
Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
4 weeks
Bulbar Hyperemia (Redness)
Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
2 weeks
Bulbar Hyperemia (Redness)
Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
4 weeks
Corneal Staining
Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
2 weeks
Corneal Staining
Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
4 weeks
Study Arms (5)
senofilcon A
ACTIVE COMPARATORcontact lens
lotrafilcon B
ACTIVE COMPARATORcontact lens
balafilcon A
ACTIVE COMPARATORcontact lens
methafilcon A
ACTIVE COMPARATORcontact lens
vifilcon A
ACTIVE COMPARATORcontact lens
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must:
- be existing soft contact lens wearers of the study control lenses
- require a distance visual correction in both eyes
- have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
- have astigmatism less than or equal to 1.00D in both eyes
- be able to wear lenses available for this study
- be corrected to a visual acuity of 6/9 (20/30) or better in each eye
- have normal eyes with no evidence of abnormality or disease
You may not qualify if:
- Subject are excluded for the following reasons:
- monovision corrected
- worn lenses extended wear in the last 3 months.
- require concurrent ocular medication
- grade 3 or 4 abnormalities
- grade 3 corneal staining in more than two regions
- anterior ocular surgery
- any other ocular surgery or injury within 8 weeks prior to study enrollment
- abnormal lachrymal secretions
- pre-existing ocular irritation that would preclude contact lens fitting
- corneal irregularities
- Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
- any systemic illness which would preclude contact lens wear
- diabetes
- infectious or immunosuppressive disease
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Salvador, Estado de Bahia, 41810-570, Brazil
Unknown Facility
Maringá, Paraná, 87014-110, Brazil
Unknown Facility
Recife, Pernambuco, 51020-031, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 22640-100, Brazil
Unknown Facility
Campinas, São Paulo, 13092-320, Brazil
Unknown Facility
Marília, São Paulo, 17519-030, Brazil
Unknown Facility
Ribeirão Preto, São Paulo, 14049-900, Brazil
Unknown Facility
Santo André, São Paulo, 09060-650, Brazil
Unknown Facility
São Paulo, São Paulo, 04063-000, Brazil
Unknown Facility
São Paulo, São Paulo, 04534-000, Brazil
Unknown Facility
São Paulo, São Paulo, 05409-001, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carlos E Leite Arieta MD, PhD
- Organization
- University of Campinas, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos E Leite Arieta, MD, PhD
Associate Professor - Ophthalmolgy, University of Campinas, Brazil
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 3, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
June 19, 2018
Results First Posted
April 28, 2014
Record last verified: 2017-08