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Comparative Clinical Evaluation of Soft Toric Lens Designs

Primary Purpose

Astigmatism, Myopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
etafilcon A
nelfilcon A
Filcon II 3
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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be greater than or equal to 18 years old.
  • Read, understand, and sign written Statement of Informed Consent.
  • Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
  • Require a visual correction in both eyes (monovision allowed but no monofit).
  • Have a spherical contact lens requirement in the range -0.50D to -6.00D.
  • Have astigmatism of between -0.50 and -2.00DC in both eyes.
  • Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction.
  • Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery

Exclusion Criteria:

  • Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
  • Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Extended lens wear in last 3 months.
  • Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
  • Any systemic disease affecting ocular health.
  • Abnormal lacrimal secretions.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial.
  • Any previous anterior ocular surgery.
  • Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis).
  • Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
  • Subjects who are known to have diabetes.
  • Employees or family members of the Research site, Principal Investigator or study team.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

etafilcon A / nelfilcon A / Filcon II 3

nelfilcon A / etafilcon A / Filcon II 3

Arm Description

etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third.

nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third.

Outcomes

Primary Outcome Measures

Phase I: Absolute Lens Rotation
At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.
Phase I: Absolute Lens Rotation
Lens orientation position as assessed on a scale of 0-180 on both eyes.

Secondary Outcome Measures

Phase I: Time to Lens Settling
With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.
Phase I: Number of Blinks Until Settled
Number of blinks for the right eye was counted until lens settling using headcam video.

Full Information

First Posted
March 9, 2012
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01552876
Brief Title
Comparative Clinical Evaluation of Soft Toric Lens Designs
Official Title
Comparative Clinical Evaluation of Soft Toric Lens Designs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is evaluating the initial fit of toric contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism, Myopia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
etafilcon A / nelfilcon A / Filcon II 3
Arm Type
Other
Arm Description
etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third.
Arm Title
nelfilcon A / etafilcon A / Filcon II 3
Arm Type
Other
Arm Description
nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Other Intervention Name(s)
1-DAY ACUVUE MOIST for Astigmatism
Intervention Description
A daily wear contact lens
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Other Intervention Name(s)
Focus Dailies Toric All Day Comfort
Intervention Description
A daily wear contact lens
Intervention Type
Device
Intervention Name(s)
Filcon II 3
Other Intervention Name(s)
Clariti(TM) 1 day Toric
Intervention Description
a daily disposable
Primary Outcome Measure Information:
Title
Phase I: Absolute Lens Rotation
Description
At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.
Time Frame
At 1-min after lens insertion during Phase I
Title
Phase I: Absolute Lens Rotation
Description
Lens orientation position as assessed on a scale of 0-180 on both eyes.
Time Frame
3 min after lens insertion during Phase I
Secondary Outcome Measure Information:
Title
Phase I: Time to Lens Settling
Description
With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.
Time Frame
5 minutes after lens insertion during Phase I
Title
Phase I: Number of Blinks Until Settled
Description
Number of blinks for the right eye was counted until lens settling using headcam video.
Time Frame
Baseline to 5 minutes during Phase I
Other Pre-specified Outcome Measures:
Title
Phase II: Absolute Rotation
Description
Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.
Time Frame
1-minute during Phase II

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be greater than or equal to 18 years old. Read, understand, and sign written Statement of Informed Consent. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). Require a visual correction in both eyes (monovision allowed but no monofit). Have a spherical contact lens requirement in the range -0.50D to -6.00D. Have astigmatism of between -0.50 and -2.00DC in both eyes. Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction. Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery Exclusion Criteria: Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months. Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear. Extended lens wear in last 3 months. Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance. Any systemic disease affecting ocular health. Abnormal lacrimal secretions. Keratoconus or other corneal irregularity. Pregnancy, lactating or planning a pregnancy at the time of enrolment. Participation in any concurrent clinical trial. Any previous anterior ocular surgery. Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis). Subjects who are known to have an immunosuppressive disease (e.g., HIV positive). Subjects who are known to have diabetes. Employees or family members of the Research site, Principal Investigator or study team.
Facility Information:
City
Farnham
ZIP/Postal Code
GU9 7EN
Country
United Kingdom

12. IPD Sharing Statement

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Comparative Clinical Evaluation of Soft Toric Lens Designs

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