search
Back to results

Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
senofilcon A
balafilcon A
omafilcon A
lotrafilcon B
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring astigmatism, visual acuity, orientation, contact lenses

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 2 LSBO

Group 3 LOSB

Group 4 LBSO

Group 5 LBOS

Group 6 SLOB

Group 7 SLBO

Group 8 SOLB

Group 9 SBLO

Group 10 SBOL

Group 11 OSLB

Group 12 OSBL

Group 13 OBLS

Group 14 OBSL

Group 15 BLSO

Group 16 BLOS

Group 17 BSOL

Group 18 BOLS

Group 19 BOSL

Group 1 LSOB

Arm Description

contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric

contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric

contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric

contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A

contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric

contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric

contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric

contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric

contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric

contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric

contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric

contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric

contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric

contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric

contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric

contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric

contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric

contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric

contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
University of Manchester
search

1. Study Identification

Unique Protocol Identification Number
NCT00584831
Brief Title
Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
Official Title
Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
University of Manchester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
astigmatism, visual acuity, orientation, contact lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2 LSBO
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
Arm Title
Group 3 LOSB
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
Arm Title
Group 4 LBSO
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
Arm Title
Group 5 LBOS
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
Arm Title
Group 6 SLOB
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
Arm Title
Group 7 SLBO
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
Arm Title
Group 8 SOLB
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
Arm Title
Group 9 SBLO
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
Arm Title
Group 10 SBOL
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
Arm Title
Group 11 OSLB
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
Arm Title
Group 12 OSBL
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
Arm Title
Group 13 OBLS
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
Arm Title
Group 14 OBSL
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
Arm Title
Group 15 BLSO
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
Arm Title
Group 16 BLOS
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
Arm Title
Group 17 BSOL
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
Arm Title
Group 18 BOLS
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
Arm Title
Group 19 BOSL
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
Arm Title
Group 1 LSOB
Arm Type
Active Comparator
Arm Description
contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
balafilcon A
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
omafilcon A
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Intervention Description
toric contact lens
Primary Outcome Measure Information:
Title
Visual Acuity After Infero-temporal Version Movement.
Description
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.
Time Frame
10 minutes after insertion
Title
Visual Acuity After Infero-nasal Version Movement.
Description
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.
Time Frame
10 minutes after lens insertion
Title
Visual Acuity After Superior-temporal Version Movement
Description
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.
Time Frame
10 minutes after lens insertion
Title
Visual Acuity After Superior-nasal Version Movement.
Description
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.
Time Frame
10 minutes after lens insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD MCOptom
Organizational Affiliation
Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
City
Manchester
ZIP/Postal Code
M60 1QD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

We'll reach out to this number within 24 hrs