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Performance of Two Toric Silicone Hydrogel Contact Lenses

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
fanfilcon A toric lens
senofilcon A toric lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft contact lens wearer
  • Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
  • Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion Criteria:

  • Has a CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (past or present)
  • Seborrheic eczema, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

Sites / Locations

  • Optometry Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fanfilcon A toric lens

senofilcon A toric lens

Arm Description

Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.

Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.

Outcomes

Primary Outcome Measures

Lens Centration
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Lens Centration
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Corneal Coverage
Lens covering the cornea (Yes, No)
Corneal Coverage
Lens covering the cornea (Yes, No)
Post Blink Movement
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Post Blink Movement
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

Secondary Outcome Measures

Wearing Time
Average daily wearing time (hours/day)
Comfortable Wearing Time
Comfortable daily wearing time (hours/day)

Full Information

First Posted
June 25, 2018
Last Updated
November 21, 2019
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03578926
Brief Title
Performance of Two Toric Silicone Hydrogel Contact Lenses
Official Title
Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.
Detailed Description
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.
Masking
ParticipantInvestigator
Masking Description
Double masked (participant and investigator)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fanfilcon A toric lens
Arm Type
Experimental
Arm Description
Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.
Arm Title
senofilcon A toric lens
Arm Type
Active Comparator
Arm Description
Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.
Intervention Type
Device
Intervention Name(s)
fanfilcon A toric lens
Other Intervention Name(s)
Avaira Vitality toric lens
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A toric lens
Other Intervention Name(s)
Acuvue Oasys for Astigmatism
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Lens Centration
Description
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Time Frame
Baseline
Title
Lens Centration
Description
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Time Frame
2 weeks
Title
Corneal Coverage
Description
Lens covering the cornea (Yes, No)
Time Frame
Baseline
Title
Corneal Coverage
Description
Lens covering the cornea (Yes, No)
Time Frame
2 weeks
Title
Post Blink Movement
Description
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Time Frame
Baseline
Title
Post Blink Movement
Description
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Wearing Time
Description
Average daily wearing time (hours/day)
Time Frame
2 weeks
Title
Comfortable Wearing Time
Description
Comfortable daily wearing time (hours/day)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted soft contact lens wearer Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive) Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes. Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit schedule Exclusion Criteria: Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Velázquez Guerrero, MSc., FIACLE
Organizational Affiliation
School of Optometry, National Autonomous University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Performance of Two Toric Silicone Hydrogel Contact Lenses

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