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Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

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ClinicalTrials.gov Identifier: NCT00584831
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : November 1, 2011
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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).

Condition or disease Intervention/treatment Phase
Astigmatism Device: senofilcon A Device: balafilcon A Device: omafilcon A Device: lotrafilcon B Not Applicable

Detailed Description:
Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
Study Start Date : October 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Eye Wear
U.S. FDA Resources

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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
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
Device: senofilcon A
toric contact lens
Device: balafilcon A
toric contact lens
Device: omafilcon A
toric contact lens
Device: lotrafilcon B
toric contact lens



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They are aged between 18-39 years.
  2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They can attain at least 6/9 in each eye with their spectacle refraction.
  5. They have successfully worn contact lenses within six months of starting the study.
  6. They can be fitted with toric soft contact lenses to match the available power range.

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They are aphakic.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or lactating.
  8. 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.
  9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584831


Locations
United Kingdom
Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
Manchester, United Kingdom, M60 1QD
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
University of Manchester
Investigators
Principal Investigator: Philip Morgan, PhD MCOptom Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00584831     History of Changes
Other Study ID Numbers: CR-0725
J07-416
First Posted: January 2, 2008    Key Record Dates
Results First Posted: November 1, 2011
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by Johnson & Johnson Vision Care, Inc.:
astigmatism
visual acuity
orientation
contact lenses

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases