AmetropiaNCT03835221
Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
A study testing methafilcon A toric contact lenses and fanfilcon A toric contact lenses in people with Ametropia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ametropia
- What is being tested?
- methafilcon A toric contact lenses and fanfilcon A toric contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2019to 6 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 - 8.00 (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.
Show all 11Show fewer
- 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
Who cannot join
- Has a Contact Lens (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 Contact Lens (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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.
- Conditions
- Ametropia
- Being tested
- methafilcon A toric contact lenses, fanfilcon A toric contact lenses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methafilcon A toric contact lensesDevice
Bilateral daily wear of methafilcon A toric contact lenses
fanfilcon A toric contact lensesDevice
Bilateral daily wear of fanfilcon A toric contact lenses
| Study group | Role | What they receive |
|---|---|---|
| methafilcon A toric / fanfilcon A toric contact lenses | Experimental | All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. Receives: Device: methafilcon A toric contact lenses; Device: fanfilcon A toric contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: Baseline
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 4 weeks
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: Baseline
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 2 weeks
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 4 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Measured: Baseline
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Measured: 4 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Measured: Baseline
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Measured: 2 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Measured: 4 weeks
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: 4 weeks
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: 2 weeks
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: 4 weeks
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Measured: Baseline
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Measured: 4 weeks
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Measured: Baseline
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Measured: 2 weeks
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Measured: 4 weeks
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Measured: Baseline
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Measured: 4 weeks
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Measured: Baseline
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Measured: 2 weeks
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Measured: 4 weeks
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Measured: Baseline
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Measured: 4 weeks
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Measured: Baseline
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Measured: 2 weeks
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Measured: 4 weeks
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Measured: Baseline
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Measured: 4 weeks
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Measured: Baseline
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Measured: 2 weeks
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Measured: 4 weeks
Secondary outcomes (6)
Average Daily Wearing Time - Methafilcon A Toric Contact Lenses
Average daily wearing time response by the subject
Measured: 4 weeks
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
Average daily wearing time response by the subject
Measured: 2 weeks
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
Average daily wearing time response by the subject
Measured: 4 weeks
Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses
Average comfortable wearing time - response by the subject
Measured: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
Average comfortable wearing time - response by the subject
Measured: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
Average comfortable wearing time - response by the subject
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Jan 2019
- Primary completion27 Mar 2019
- Study completion6 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmetropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Velazquez, MSc FIACLE, Principal investigator, School of Optometry, National Autonomous University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835221
- Sponsor's protocol ID
- EX-MKTG-96
- Status last verified
- May 2020
- First submitted
- 31 Jan 2019
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
- ClinicalTrials.gov ID
- NCT03835221
- Acronym / sponsor ID
- EX-MKTG-96
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methafilcon A toric / fanfilcon A toric contact lenses | Experimental | Device: methafilcon A toric contact lenses, Device: fanfilcon A toric contact lensesAll subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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 - 8.00 (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.
Key exclusion criteria (20 listed)
- Has a Contact Lens (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 Contact Lens (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methafilcon A toric contact lensesBilateral daily wear of methafilcon A toric contact lenses | Device | methafilcon A toric / fanfilcon A toric contact lenses |
| fanfilcon A toric contact lensesBilateral daily wear of fanfilcon A toric contact lenses | Device | methafilcon A toric / fanfilcon A toric contact lenses |
Primary outcome
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: Baseline
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: Baseline
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: Baseline
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: Baseline
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: Baseline
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: Baseline
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Time frame: Baseline
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Time frame: 4 weeks
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: Baseline
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: Baseline
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: Baseline
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: Baseline
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: Baseline
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: Baseline
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: Baseline
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
6 secondary outcomes
Average Daily Wearing Time - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses
Time frame: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
Time frame: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Refractive Ametropia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Velazquez, MSc FIACLE principal investigator
School of Optometry, National Autonomous University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methafilcon A toric contact lenses and fanfilcon A toric contact lenses in people with Ametropia, run by CooperVision, Inc. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses (time frame: Baseline). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.