Astigmatism
Conditions
Brief summary
The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.
Detailed description
This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.
Interventions
DEVICEfilcon IV1 toric lens
toric contact lens
DEVICEocufilcon D toric lens
toric contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 toric contact lens wearer * Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive) * Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Patient contact lens refraction should fit within the available parameters of the study lenses. * Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule
Exclusion criteria
* A person will be excluded from the study if he/she: * Has a CL prescription outside the range of the available parameters of the study lenses. * Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. * Presence of clinically significant (grade 2-4) anterior segment abnormalities * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Fit Acceptance | Baseline and 1 week | Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect |
| Lens Centration | Baseline and 1 week | Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered). |
| Post-blink Movement | Baseline and 1 week | Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement. |
| Overall Stability | Baseline and 1 week | Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability. |
| Corneal Coverage | Baseline and 1 week | Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage) |
| Lens Orientation in Primary Position of Gaze | Baseline and 1 week | Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead. |
| Rotational Recovery in Degrees After 60 Seconds | Baseline and 1 week | Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Participants are randomized to wear filcon IV1 or ocufilcon D toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
ocufilcon D: toric contact lens | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 5.8 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Corneal Coverage
Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens (Baseline) | Corneal Coverage | Habitual toric lens - Yes | 29 participants |
| Habitual Lens (Baseline) | Corneal Coverage | Habitual toric lens - No | 0 participants |
| Habitual Lens (Baseline) | Corneal Coverage | Baseline - Yes | 29 participants |
| Habitual Lens (Baseline) | Corneal Coverage | Baseline - No | 0 participants |
| Habitual Lens (Baseline) | Corneal Coverage | 1 week - Yes | 29 participants |
| Habitual Lens (Baseline) | Corneal Coverage | 1 week - No | 0 participants |
| Filcon IV1 Toric Lens (Baseline) | Corneal Coverage | 1 week - Yes | 29 participants |
| Filcon IV1 Toric Lens (Baseline) | Corneal Coverage | Habitual toric lens - Yes | 29 participants |
| Filcon IV1 Toric Lens (Baseline) | Corneal Coverage | Baseline - No | 0 participants |
| Filcon IV1 Toric Lens (Baseline) | Corneal Coverage | Habitual toric lens - No | 0 participants |
| Filcon IV1 Toric Lens (Baseline) | Corneal Coverage | 1 week - No | 0 participants |
| Filcon IV1 Toric Lens (Baseline) | Corneal Coverage | Baseline - Yes | 29 participants |
Primary
Lens Centration
Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens (Baseline) | Lens Centration | 1 week - filcon IV1 toric | 100 percentage of participants |
| Habitual Lens (Baseline) | Lens Centration | Baseline - ocufilcon D toric | 100 percentage of participants |
| Habitual Lens (Baseline) | Lens Centration | Habitual toric lens | 100 percentage of participants |
| Habitual Lens (Baseline) | Lens Centration | Baseline - filcon IV1 toric | 100 percentage of participants |
| Habitual Lens (Baseline) | Lens Centration | 1 week - ocufilcon D toric | 100 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Centration | Baseline - ocufilcon D toric | 0 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Centration | Habitual toric lens | 0 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Centration | Baseline - filcon IV1 toric | 0 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Centration | 1 week - filcon IV1 toric | 0 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Centration | 1 week - ocufilcon D toric | 0 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Centration | 1 week - ocufilcon D toric | 0 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Centration | 1 week - filcon IV1 toric | 0 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Centration | Habitual toric lens | 0 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Centration | Baseline - ocufilcon D toric | 0 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Centration | Baseline - filcon IV1 toric | 0 percentage of participants |
Primary
Lens Orientation in Primary Position of Gaze
Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens (Baseline) | Lens Orientation in Primary Position of Gaze | 0 degrees | 62 percentage of participants |
| Habitual Lens (Baseline) | Lens Orientation in Primary Position of Gaze | <=10 degrees | 3 percentage of participants |
| Habitual Lens (Baseline) | Lens Orientation in Primary Position of Gaze | <=5 degrees | 35 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Orientation in Primary Position of Gaze | <=5 degrees | 21 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Orientation in Primary Position of Gaze | 0 degrees | 72 percentage of participants |
| Filcon IV1 Toric Lens (Baseline) | Lens Orientation in Primary Position of Gaze | <=10 degrees | 7 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Orientation in Primary Position of Gaze | <=5 degrees | 21 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Orientation in Primary Position of Gaze | 0 degrees | 76 percentage of participants |
| Ocufilcon D Toric Lens (Baseline) | Lens Orientation in Primary Position of Gaze | <=10 degrees | 3 percentage of participants |
| Filcon IV1 Toric Lens (1 Week) | Lens Orientation in Primary Position of Gaze | 0 degrees | 79 percentage of participants |
| Filcon IV1 Toric Lens (1 Week) | Lens Orientation in Primary Position of Gaze | <=10 degrees | 14 percentage of participants |
| Filcon IV1 Toric Lens (1 Week) | Lens Orientation in Primary Position of Gaze | <=5 degrees | 7 percentage of participants |
| Ocufilcon D Toric Lens (1 Week) | Lens Orientation in Primary Position of Gaze | <=5 degrees | 14 percentage of participants |
| Ocufilcon D Toric Lens (1 Week) | Lens Orientation in Primary Position of Gaze | 0 degrees | 79 percentage of participants |
| Ocufilcon D Toric Lens (1 Week) | Lens Orientation in Primary Position of Gaze | <=10 degrees | 7 percentage of participants |
Primary
Overall Fit Acceptance
Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect
Time frame: Baseline and 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Overall Fit Acceptance | 3.8 units on a scale | Standard Deviation 0.5 |
| Filcon IV1 Toric Lens (Baseline) | Overall Fit Acceptance | 3.5 units on a scale | Standard Deviation 0.5 |
| Ocufilcon D Toric Lens (Baseline) | Overall Fit Acceptance | 3.7 units on a scale | Standard Deviation 0.5 |
| Filcon IV1 Toric Lens (1 Week) | Overall Fit Acceptance | 3.8 units on a scale | Standard Deviation 0.4 |
| Ocufilcon D Toric Lens (1 Week) | Overall Fit Acceptance | 3.7 units on a scale | Standard Deviation 0.5 |
Primary
Overall Stability
Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.
Time frame: Baseline and 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Overall Stability | 3.8 units on a scale | Standard Deviation 0.5 |
| Filcon IV1 Toric Lens (Baseline) | Overall Stability | 3.6 units on a scale | Standard Deviation 0.5 |
| Ocufilcon D Toric Lens (Baseline) | Overall Stability | 3.8 units on a scale | Standard Deviation 0.4 |
| Filcon IV1 Toric Lens (1 Week) | Overall Stability | 3.7 units on a scale | Standard Deviation 0.5 |
| Ocufilcon D Toric Lens (1 Week) | Overall Stability | 3.7 units on a scale | Standard Deviation 0.6 |
Primary
Post-blink Movement
Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.
Time frame: Baseline and 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Post-blink Movement | 1.97 units on a scale | Standard Deviation 0.5 |
| Filcon IV1 Toric Lens (Baseline) | Post-blink Movement | 2.1 units on a scale | Standard Deviation 0.3 |
| Ocufilcon D Toric Lens (Baseline) | Post-blink Movement | 2.1 units on a scale | Standard Deviation 0.4 |
| Filcon IV1 Toric Lens (1 Week) | Post-blink Movement | 2.0 units on a scale | Standard Deviation 0.3 |
| Ocufilcon D Toric Lens (1 Week) | Post-blink Movement | 2.2 units on a scale | Standard Deviation 0.4 |
Primary
Rotational Recovery in Degrees After 60 Seconds
Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.
Time frame: Baseline and 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Rotational Recovery in Degrees After 60 Seconds | 4.1 degrees | Standard Deviation 6.7 |
| Filcon IV1 Toric Lens (Baseline) | Rotational Recovery in Degrees After 60 Seconds | 5.0 degrees | Standard Deviation 7.1 |
| Ocufilcon D Toric Lens (Baseline) | Rotational Recovery in Degrees After 60 Seconds | 3.3 degrees | Standard Deviation 4.7 |
| Filcon IV1 Toric Lens (1 Week) | Rotational Recovery in Degrees After 60 Seconds | 2.2 degrees | Standard Deviation 4.1 |
| Ocufilcon D Toric Lens (1 Week) | Rotational Recovery in Degrees After 60 Seconds | 3.8 degrees | Standard Deviation 8.5 |