Back to resultsFitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Omafilcon A
Somofilcon A
Omafilcon A - Proclear (PC)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- 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 CL (Contact Lens) wearer who is not wearing any of the study lenses.
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
- 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.
- Is willing to comply with the visit schedule.
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to - 6.00D
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- 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 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Omafilcon A
Somofilcon A
Omafilcon A - Proclear (PC)
Arm Description
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Outcomes
Primary Outcome Measures
Visual Acuity
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Comfort
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Lens Fit Acceptance
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Lens Fit Acceptance
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Lens Fit Preference
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Limbal Redness
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
Bulbar Redness
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03098745
Brief Title
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
Official Title
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
April 11, 2017 (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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
Detailed Description
This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omafilcon A
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Arm Title
Somofilcon A
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Arm Title
Omafilcon A - Proclear (PC)
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Intervention Type
Device
Intervention Name(s)
Omafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Somofilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Omafilcon A - Proclear (PC)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Time Frame
Baseline (lens insertion), 1 hour
Title
Comfort
Description
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Time Frame
Insertion, 1hr
Title
Lens Centration
Description
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Time Frame
Insertion
Title
Lens Centration
Description
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Time Frame
1 Hour
Title
Post-blink Lens Movement
Description
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Time Frame
Insertion
Title
Post-blink Lens Movement
Description
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Time Frame
1 Hour
Title
Lens Fit Acceptance
Description
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Time Frame
Insertion
Title
Lens Fit Acceptance
Description
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Time Frame
1 Hour
Title
Lens Fit Preference
Description
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Time Frame
1 Hour
Title
Limbal Redness
Description
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
Time Frame
1 Hour
Title
Bulbar Redness
Description
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Time Frame
1 Hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
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 CL (Contact Lens) wearer who is not wearing any of the study lenses.
Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
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.
Is willing to comply with the visit schedule.
Exclusion Criteria:
A person will be excluded from the study if he/she:
Has never worn contact lenses before.
Currently wears rigid gas permeable contact lenses.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has a CL prescription outside the range of - 1.00 to - 6.00D
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
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
National Autonomous University, School of Optometry
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
Learn more about this trial
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
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