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Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
senofilcon A
balafilcon A toric
lotrafilcon B toric
omafilcon A
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, orientation, visual acuity, contact lenses

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. be at least 18 and less than or equal to 50 years of age
  2. be able and willing to adhere to the instructions set forth in the protocol.
  3. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
  4. Sign the STATEMENT OF INFORMED CONSENT.
  5. Have normal, healthy eyes

Exclusion Criteria:

  1. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
  2. Pre-existing ocular disease precluding contact lens fitting.
  3. Insufficient lacrimal secretions
  4. Aphakia, keratoconus or a highly irregular cornea
  5. Previous eye surgery involving the anterior segment
  6. Current pregnancy or lactation (to the best of the subject's knowledge).
  7. Use of concurrent ocular medication
  8. Active participation in another clinical study at any time during this study.-

Sites / Locations

  • Visioncare Research Ltd.

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 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

Arm Label

Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A

Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A

Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A

Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A

Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B

Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A

Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A

Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A

Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A

Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A

Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B

Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A

Arm Description

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A

Outcomes

Primary Outcome Measures

Lens Orientation During Head Tilt.
Degree of lens rotation on the eye with the head tilted.
Visual Acuity During Head Tilt
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

Degree of Lens Rotation in Superior Gaze.
Degree of lens rotation while participant is gazing up.
Degree of Lens Rotation in Superior-temporal Gaze.
Degree of lens rotation while participant is gazing up and out(towards the temple).
Degree of Lens Rotation in Superior-nasal Gaze.
Degree of lens rotation while participant is gazing up and in(towards the nose).
Degree of Lens Rotation in Temporal Gaze.
Degree of lens rotation while participant is gazing out(towards the temple).
Degree of Lens Rotation in Nasal Gaze.
Degree of lens rotation while participant is gazing in(towards the nose).
Degree of Lens Rotation Inferior-temporal Gaze.
Degree of lens rotation while participant is gazing down and out.
Degree of Lens Rotation in Inferior-nasal Gaze.
Degree of lens rotation while participant is gazing down and in.
Degree of Lens Rotation in Inferior Gaze.
Degree of lens rotation while participant is gazing down.

Full Information

First Posted
December 21, 2007
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00583908
Brief Title
Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
Official Title
Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.
Detailed Description
Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A
Arm Title
Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A
Arm Title
Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A
Arm Title
Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A
Arm Title
Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B
Arm Title
Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Arm Title
Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A
Arm Title
Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A
Arm Title
Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A
Arm Title
Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Arm Title
Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B
Arm Title
Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A
Arm Type
Active Comparator
Arm Description
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
balafilcon A toric
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
lotrafilcon B toric
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
omafilcon A
Intervention Description
toric contact lens
Primary Outcome Measure Information:
Title
Lens Orientation During Head Tilt.
Description
Degree of lens rotation on the eye with the head tilted.
Time Frame
after fit of each of the four lens insertions
Title
Visual Acuity During Head Tilt
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
after each of the four lens insertions
Secondary Outcome Measure Information:
Title
Degree of Lens Rotation in Superior Gaze.
Description
Degree of lens rotation while participant is gazing up.
Time Frame
After each of the four lens insertions
Title
Degree of Lens Rotation in Superior-temporal Gaze.
Description
Degree of lens rotation while participant is gazing up and out(towards the temple).
Time Frame
After each of 4 lens insertions.,
Title
Degree of Lens Rotation in Superior-nasal Gaze.
Description
Degree of lens rotation while participant is gazing up and in(towards the nose).
Time Frame
After each of the four lens insertions
Title
Degree of Lens Rotation in Temporal Gaze.
Description
Degree of lens rotation while participant is gazing out(towards the temple).
Time Frame
After each of the four lens insertions
Title
Degree of Lens Rotation in Nasal Gaze.
Description
Degree of lens rotation while participant is gazing in(towards the nose).
Time Frame
After each of the four lens insertions
Title
Degree of Lens Rotation Inferior-temporal Gaze.
Description
Degree of lens rotation while participant is gazing down and out.
Time Frame
After each of the four lens insertions
Title
Degree of Lens Rotation in Inferior-nasal Gaze.
Description
Degree of lens rotation while participant is gazing down and in.
Time Frame
After each of the four lens insertions
Title
Degree of Lens Rotation in Inferior Gaze.
Description
Degree of lens rotation while participant is gazing down.
Time Frame
After each of the four lens insertions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be at least 18 and less than or equal to 50 years of age be able and willing to adhere to the instructions set forth in the protocol. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D Sign the STATEMENT OF INFORMED CONSENT. Have normal, healthy eyes Exclusion Criteria: The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear. Pre-existing ocular disease precluding contact lens fitting. Insufficient lacrimal secretions Aphakia, keratoconus or a highly irregular cornea Previous eye surgery involving the anterior segment Current pregnancy or lactation (to the best of the subject's knowledge). Use of concurrent ocular medication Active participation in another clinical study at any time during this study.-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Young, BSc, MPhil
Organizational Affiliation
Visioncare Research Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Visioncare Research Ltd.
City
Farnham
ZIP/Postal Code
GU9 7EN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

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