Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
1 other identifier
interventional
35
1 country
1
Brief Summary
The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
February 6, 2018
CompletedFebruary 6, 2018
July 1, 2017
1 month
March 30, 2016
March 28, 2017
July 20, 2017
Conditions
Outcome Measures
Primary Outcomes (20)
Centration - Pair One
Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Baseline and 1 hour
Centration - Pair Two
Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Baseline and 1 hour
Centration - Pair Three
Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Baseline and 1 hour
Centration - Pair Four
Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Baseline and 1 hour
Post-blink Movement - Pair One
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Baseline
Post-blink Movement - Pair One
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
1 hour
Post-blink Movement - Pair Two
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Baseline
Post-blink Movement - Pair Two
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
1 hour
Post-blink Movement - Pair Three
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Baseline
Post-blink Movement - Pair Three
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
1 hour
Post-blink Movement - Pair Four
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Baseline
Post-blink Movement - Pair Four
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
1 hour
Lens Tightness - Pair One
Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Baseline and 1 hour
Lens Tightness - Pair Two
Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Baseline and 1 hour
Lens Tightness - Pair Three
Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Baseline and 1 hour
Lens Tightness - Pair Four
Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Baseline and 1 hour
Overall Fit Preference - Pair One
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.
Baseline and 1 hour
Overall Fit Acceptance - Pair Two
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.
Baseline and 1 hour
Overall Fit Acceptance - Pair Three
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.
Baseline and 1 hour
Overall Fit Acceptance - Pair Four
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.
Baseline and 1 hour
Study Arms (4)
filcon IV I (BC 8.6) / ocufilcon D (pair one)
EXPERIMENTALParticipants were randomized to a test and control lens for each pair in a contralateral design.
filcon IV I (BC 8.7) / ocufilcon D (pair two)
EXPERIMENTALParticipants were randomized to a test and control lens for each pair in a contralateral design.
methafilcon A (BC 8.6) / ocufilcon D (pair three)
EXPERIMENTALParticipants were randomized to a test and control lens for each pair in a contralateral design.
methafilcon A (BC 8.7) / somofilcon A (pair four)
EXPERIMENTALParticipants were randomized to a test and control lens for each pair in a contralateral design.
Interventions
test lens
Eligibility Criteria
You may qualify if:
- 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.
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D (Diopters) 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.
You may not qualify if:
- 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 (GPC) worse than grade 1
- Anterior uveitis or iritis (past or present)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Optometry Clinic, National Autonomous University
Mexico City, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager Global Medical Scientific Affairs
- Organization
- CooperVision Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 5, 2016
Study Start
April 1, 2016
Primary Completion
May 1, 2016
Study Completion
August 1, 2016
Last Updated
February 6, 2018
Results First Posted
February 6, 2018
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share