Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
2 other identifiers
interventional
40
1 country
1
Brief Summary
The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).
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 Oct 2007
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
November 1, 2011
CompletedMay 21, 2015
May 1, 2015
4 months
December 20, 2007
September 24, 2009
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Visual Acuity After Infero-temporal Version Movement.
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
10 minutes after insertion
Visual Acuity After Infero-nasal Version Movement.
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
10 minutes after lens insertion
Visual Acuity After Superior-temporal Version Movement
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
10 minutes after lens insertion
Visual Acuity After Superior-nasal Version Movement.
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
10 minutes after lens insertion
Study Arms (19)
Group 2 LSBO
ACTIVE COMPARATORcontact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
Group 3 LOSB
ACTIVE COMPARATORcontact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
Group 4 LBSO
ACTIVE COMPARATORcontact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
Group 5 LBOS
ACTIVE COMPARATORcontact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
Group 6 SLOB
ACTIVE COMPARATORcontact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
Group 7 SLBO
ACTIVE COMPARATORcontact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
Group 8 SOLB
ACTIVE COMPARATORcontact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
Group 9 SBLO
ACTIVE COMPARATORcontact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
Group 10 SBOL
ACTIVE COMPARATORcontact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
Group 11 OSLB
ACTIVE COMPARATORcontact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
Group 12 OSBL
ACTIVE COMPARATORcontact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
Group 13 OBLS
ACTIVE COMPARATORcontact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
Group 14 OBSL
ACTIVE COMPARATORcontact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
Group 15 BLSO
ACTIVE COMPARATORcontact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
Group 16 BLOS
ACTIVE COMPARATORcontact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
Group 17 BSOL
ACTIVE COMPARATORcontact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
Group 18 BOLS
ACTIVE COMPARATORcontact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
Group 19 BOSL
ACTIVE COMPARATORcontact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
Group 1 LSOB
ACTIVE COMPARATORcontact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
Interventions
toric contact lens
toric contact lens
toric contact lens
toric contact lens
Eligibility Criteria
You may qualify if:
- They are aged between 18-39 years.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They can attain at least 6/9 in each eye with their spectacle refraction.
- They have successfully worn contact lenses within six months of starting the study.
- They can be fitted with toric soft contact lenses to match the available power range.
You may not qualify if:
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johnson & Johnson Vision Care, Inc.lead
- University of Manchestercollaborator
Study Sites (1)
Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
Manchester, M60 1QD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kurt Moody, OD, FAAO
- Organization
- Vistakon
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Morgan, PhD MCOptom
Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 2, 2008
Study Start
October 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
May 21, 2015
Results First Posted
November 1, 2011
Record last verified: 2015-05