Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

This study has been completed.
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00584831
First received: December 20, 2007
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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 Intervention
Astigmatism
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Visual Acuity After Infero-temporal Version Movement. [ Time Frame: 10 minutes after insertion ] [ Designated as safety issue: No ]
    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.

  • Visual Acuity After Infero-nasal Version Movement. [ Time Frame: 10 minutes after lens insertion ] [ Designated as safety issue: No ]
    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.

  • Visual Acuity After Superior-temporal Version Movement [ Time Frame: 10 minutes after lens insertion ] [ Designated as safety issue: No ]
    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.

  • Visual Acuity After Superior-nasal Version Movement. [ Time Frame: 10 minutes after lens insertion ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584831

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

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00584831     History of Changes
Other Study ID Numbers: CR-0725, J07-416
Study First Received: December 20, 2007
Results First Received: September 24, 2009
Last Updated: December 30, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Vistakon:
astigmatism
visual acuity
orientation
contact lenses

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 01, 2014