AstigmatismNCT02142361
Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses
A study testing enfilcon A in people with Astigmatism, run by CooperVision, Inc. at 1 site in Spain.
Trial summary
Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- enfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jul 2014
- 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 toric 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 1.75 D in both eyes.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
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- 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
Who cannot join
- Has a contact lens prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.
- Has a history of not achieving comfortable contact lens 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.
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- 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.
Spain1 site
Optometry Research Group (GIO) Optics Department, University of Valencia
Valencia, 46100
About this study
Official title: Clinical Performance of Habitual Wearers of Hydrogel Toric Lenses When Refitted With Avaira Toric Silicone Hydrogel Lenses
Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.
Read the detailed description
This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.
- Conditions
- Astigmatism
- Being tested
- enfilcon A
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enfilcon ADevice
Also called enfilcon A/Silicone Hydrogel Lens
Silicone hydrogel toric lenses.
| Study group | Role | What they receive |
|---|---|---|
| Omafilcon A/Enfilcon A | Active comparator | Subject's habitual hydrogel toric lenses Omafilcon A will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. Receives: Device: enfilcon A |
| Ocufilcon D/Enfilcon A | Active comparator | Subject's habitual hydrogel toric lenses Ocufilcon D will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. Receives: Device: enfilcon A |
| Methafilcon B/ Enfilcon A | Active comparator | Subject's habitual hydrogel toric lenses Methafilcon B will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. Receives: Device: enfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Subjective Rating for Lens Initial Comfort
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Measured: Baseline and 1 week
Participant's Subjective Rating for Lens Comfort Prior to Removal
Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Lens Comfort
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Measured: Baseline and 1 week
Participant's Subjective Rating for Dryness During the Day
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Measured: Baseline and 1 week
Participant's Subjective Rating for Dryness Prior to Removal
Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Dryness
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Measured: Baseline and 1 week
Participant's Subjective Rating for Lens Handling - Insertion
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Lens Fit Stability
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Vision Satisfaction
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)
Measured: Baseline and 1 week
Participant's Subjective Rating for Vision Quality at Insertion
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Measured: Baseline and 1 week
Participant's Subjective Rating for Vision Quality During the Day
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Measured: Baseline and 1 week
Participant's Subjective Rating for Vision Quality End of the Day
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Measured: Baseline and 1 week
Participant's Subjective Rating for Night Vision Quality
Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Measured: Baseline and 1 week
Participant's Subjective Rating for Vision Stability at Insertion
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Measured: Baseline and 1 week
Participant's Subjective Rating for Vision Stability During the Day
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Measured: Baseline and 1 week
Participant's Subjective Rating for Vision Stability at End of Day
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Measured: Baseline and 1 week
Participant's Subjective Rating for Lens Pair Preference
Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.
Measured: 1 week
Participant's Subjective Rating for Overall Satisfaction - Dryness
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Satisfaction - Handling
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Satisfaction - Vision
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Satisfaction - Lens Fit
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Satisfaction - Overall
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Measured: Baseline and 1 week
Clinician's Objective Assessment Monocular High Contrast Distance Visual
Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.
Measured: Baseline and 1 week
Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity
Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value
Measured: Baseline and 1 week
Clinician's Assessment Overall Lens Stability-Right Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Measured: Baseline and 1 week
Clinician's Assessment Overall Lens Stability-Left Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Measured: Baseline and 1 week
Clinician's Assessment Overall Fit Acceptance- Right Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Measured: Baseline and 1 week
Clinician's Assessment Overall Fit Acceptance- Left Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Measured: Baseline and 1 week
Clinician's Assessment Lens Centration-Right Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))
Measured: Baseline and 1 week
Clinician's Assessment Lens Centration- Left Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)
Measured: Baseline and 1 week
Clinician's Assessment Corneal Coverage-Right Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)
Measured: Baseline and 1 week
Clinicians Assessment Corneal Coverage-Left Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)
Measured: Baseline and 1 week
Clinician's Assessment Post-Blink Movement- Right Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Measured: Baseline and 1 week
Clinician's Assessment Post-Blink Movement-Left Eye
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Measured: Baseline and 1 week
Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Measured: Baseline and 1 week
Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Measured: Baseline and 1 week
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Measured: Baseline and 1 week
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Measured: Baseline and 1 week
Participant's Subjective Rating for Overall Satisfaction - Comfort
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionJul 2014
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 AstigmatismStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Montés-Mico, OD MPhil PhD, Principal investigator, Optometry Research Group (GIO) Optics Department, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142361
- Sponsor's protocol ID
- EX-MKTG-48
- Status last verified
- Jul 2020
- First submitted
- 16 May 2014
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Habitual Wearers of Hydrogel Toric Lenses When Refitted With Avaira Toric Silicone Hydrogel Lenses
- ClinicalTrials.gov ID
- NCT02142361
- Acronym / sponsor ID
- EX-MKTG-48
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 19 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.
Detailed description
This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omafilcon A/Enfilcon A | Active comparator | Device: enfilcon ASubject's habitual hydrogel toric lenses Omafilcon A will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. |
| Ocufilcon D/Enfilcon A | Active comparator | Device: enfilcon ASubject's habitual hydrogel toric lenses Ocufilcon D will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. |
| Methafilcon B/ Enfilcon A | Active comparator | Device: enfilcon ASubject's habitual hydrogel toric lenses Methafilcon B will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 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 toric 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 1.75 D in both eyes.
Key exclusion criteria (20 listed)
- Has a contact lens prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.
- Has a history of not achieving comfortable contact lens 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 |
|---|---|---|
| enfilcon AAlso: enfilcon A/Silicone Hydrogel LensSilicone hydrogel toric lenses. | Device | Methafilcon B/ Enfilcon A, Ocufilcon D/Enfilcon A, Omafilcon A/Enfilcon A |
Primary outcome
Participant's Subjective Rating for Lens Initial Comfort
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Participant's Subjective Rating for Lens Comfort Prior to Removal
Time frame: Baseline and 1 week
Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Participant's Subjective Rating for Overall Lens Comfort
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Participant's Subjective Rating for Dryness During the Day
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Participant's Subjective Rating for Dryness Prior to Removal
Time frame: Baseline and 1 week
Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Participant's Subjective Rating for Overall Dryness
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Participant's Subjective Rating for Lens Handling - Insertion
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)
Participant's Subjective Rating for Overall Lens Fit Stability
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)
Participant's Subjective Rating for Overall Vision Satisfaction
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)
Participant's Subjective Rating for Vision Quality at Insertion
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Vision Quality During the Day
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Vision Quality End of the Day
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Night Vision Quality
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Vision Stability at Insertion
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Participant's Subjective Rating for Vision Stability During the Day
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Participant's Subjective Rating for Vision Stability at End of Day
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Participant's Subjective Rating for Lens Pair Preference
Time frame: 1 week
Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.
Participant's Subjective Rating for Overall Satisfaction - Dryness
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Participant's Subjective Rating for Overall Satisfaction - Handling
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Participant's Subjective Rating for Overall Satisfaction - Vision
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Participant's Subjective Rating for Overall Satisfaction - Lens Fit
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Participant's Subjective Rating for Overall Satisfaction - Overall
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Clinician's Objective Assessment Monocular High Contrast Distance Visual
Time frame: Baseline and 1 week
Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.
Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity
Time frame: Baseline and 1 week
Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value
Clinician's Assessment Overall Lens Stability-Right Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Clinician's Assessment Overall Lens Stability-Left Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Clinician's Assessment Overall Fit Acceptance- Right Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Clinician's Assessment Overall Fit Acceptance- Left Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Clinician's Assessment Lens Centration-Right Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))
Clinician's Assessment Lens Centration- Left Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)
Clinician's Assessment Corneal Coverage-Right Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)
Clinicians Assessment Corneal Coverage-Left Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)
Clinician's Assessment Post-Blink Movement- Right Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Clinician's Assessment Post-Blink Movement-Left Eye
Time frame: Baseline and 1 week
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye
Time frame: Baseline and 1 week
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye
Time frame: Baseline and 1 week
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye
Time frame: Baseline and 1 week
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye
Time frame: Baseline and 1 week
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Participant's Subjective Rating for Overall Satisfaction - Comfort
Time frame: Baseline and 1 week
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Montés-Mico, OD MPhil PhD principal investigator
Optometry Research Group (GIO) Optics Department, University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enfilcon A in people with Astigmatism, run by CooperVision, Inc. at 1 site in Spain.
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 12 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 28 Jul 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 Spain. 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 19 Apr 2016). 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?
Participant's Subjective Rating for Lens Initial Comfort (time frame: Baseline and 1 week). The study lists 39 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 28 Jul 2020.