Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
May 5, 2015 updated by: Johnson & Johnson Vision Care, Inc.
Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Non-dispensing, single-masked (subject-masked), randomised, controlled study.
Two visits.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Manchester, United Kingdom, M60 1QD
- Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group 2 LSBO
contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 3 LOSB
contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 4 LBSO
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 5 LBOS
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 6 SLOB
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 7 SLBO
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 8 SOLB
contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 9 SBLO
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 10 SBOL
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 11 OSLB
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 12 OSBL
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 13 OBLS
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 14 OBSL
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 15 BLSO
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 16 BLOS
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 17 BSOL
contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 18 BOLS
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 19 BOSL
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
|
ACTIVE_COMPARATOR: Group 1 LSOB
contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
|
toric contact lens
toric contact lens
toric contact lens
toric contact lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Acuity After Infero-temporal Version Movement.
Time Frame: 10 minutes after insertion
|
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.
Time Frame: 10 minutes after lens insertion
|
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
Time Frame: 10 minutes after lens insertion
|
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.
Time Frame: 10 minutes after lens insertion
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Philip Morgan, PhD MCOptom, Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (ACTUAL)
February 1, 2008
Study Completion (ACTUAL)
February 1, 2008
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 31, 2007
First Posted (ESTIMATE)
January 2, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-0725
- J07-416
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.