Astigmatism
Conditions
Brief summary
The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.
Detailed description
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.
Interventions
DEVICEFanfilcon A toric lens
Contact lens
DEVICELotrafilcon B toric lens
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
No
Inclusion criteria
* 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 - 9.00 (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. * 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 -2.50 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. * 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 |
|---|---|---|
| Lens Centration | Baseline | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) |
| Corneal Coverage | Baseline | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) |
| Post-blink Movement | Baseline | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) |
| Overall Fit Acceptance | Dispense | Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Hours of Wear Per Day | Baseline | Number of hours lenses are worn per day |
| Average Comfortable Wearing Time | Baseline | Typical time of day when subject first experiences lens awareness or irritation. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fanfilcon A Toric vs. Lotrafilcon B Toric Contact Lens Each subject is randomized to wear either the fanfilcon A toric or lotrafilcon B toric contact lens as a matched pair and crossed over to second matched pair. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Fanfilcon A Toric vs. Lotrafilcon B Toric Contact Lens |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 27.7 years STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 42 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Mexico | 42 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Time frame: 1 Month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Corneal Coverage | Full Coverage (Yes) | 42 Participants |
| Habitual Toric Lens at Baseline | Corneal Coverage | Incomplete (No) | 0 Participants |
| Lotrafilcon B Toric at Dispense | Corneal Coverage | Incomplete (No) | 0 Participants |
| Lotrafilcon B Toric at Dispense | Corneal Coverage | Full Coverage (Yes) | 42 Participants |
Primary
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Corneal Coverage | Full Coverage (Yes) | 42 Participants |
| Habitual Toric Lens at Baseline | Corneal Coverage | Incomplete (No) | 0 Participants |
Primary
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Time frame: Dispense
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Corneal Coverage | Full Coverage (Yes) | 42 Participants |
| Habitual Toric Lens at Baseline | Corneal Coverage | Incomplete (No) | 0 Participants |
| Lotrafilcon B Toric at Dispense | Corneal Coverage | Full Coverage (Yes) | 42 Participants |
| Lotrafilcon B Toric at Dispense | Corneal Coverage | Incomplete (No) | 0 Participants |
Primary
Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Lens Centration | 1-Optimal Centration | 41 Participants |
| Habitual Toric Lens at Baseline | Lens Centration | 2-Decentration acceptable | 1 Participants |
| Habitual Toric Lens at Baseline | Lens Centration | 3-Decentranation Unacceptable | 0 Participants |
Primary
Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Time frame: 1 Month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Lens Centration | 1-Optimal Centration | 42 Participants |
| Habitual Toric Lens at Baseline | Lens Centration | 2-Decentration acceptable | 0 Participants |
| Habitual Toric Lens at Baseline | Lens Centration | 3-Decentranation Unacceptable | 0 Participants |
| Lotrafilcon B Toric at Dispense | Lens Centration | 1-Optimal Centration | 42 Participants |
| Lotrafilcon B Toric at Dispense | Lens Centration | 2-Decentration acceptable | 0 Participants |
| Lotrafilcon B Toric at Dispense | Lens Centration | 3-Decentranation Unacceptable | 0 Participants |
Primary
Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Time frame: Dispense
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Lens Centration | 1-Optimal Centration | 42 Participants |
| Habitual Toric Lens at Baseline | Lens Centration | 2-Decentration acceptable | 0 Participants |
| Habitual Toric Lens at Baseline | Lens Centration | 3-Decentranation Unacceptable | 0 Participants |
| Lotrafilcon B Toric at Dispense | Lens Centration | 1-Optimal Centration | 42 Participants |
| Lotrafilcon B Toric at Dispense | Lens Centration | 2-Decentration acceptable | 0 Participants |
| Lotrafilcon B Toric at Dispense | Lens Centration | 3-Decentranation Unacceptable | 0 Participants |
Primary
Overall Fit Acceptance
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Overall Fit Acceptance | 3.8 units on a scale | Standard Deviation 0.5 |
| Lotrafilcon B Toric at Dispense | Overall Fit Acceptance | 2.4 units on a scale | Standard Deviation 1 |
Primary
Overall Fit Acceptance
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Overall Fit Acceptance | 3.9 units on a scale | Standard Deviation 0.4 |
| Lotrafilcon B Toric at Dispense | Overall Fit Acceptance | 2.5 units on a scale | Standard Deviation 0.9 |
Primary
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Post-blink Movement | 2.02 score on a scale | Standard Deviation 0.2 |
| Lotrafilcon B Toric at Dispense | Post-blink Movement | 2.05 score on a scale | Standard Deviation 0.5 |
Primary
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Post-blink Movement | 2.17 score on a scale | Standard Deviation 0.5 |
Primary
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Post-blink Movement | 2.00 score on a scale | Standard Deviation 0 |
| Lotrafilcon B Toric at Dispense | Post-blink Movement | 2.10 score on a scale | Standard Deviation 0.4 |
Secondary
Average Comfortable Wearing Time
Typical time of day when subject first experiences lens awareness or irritation.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Average Comfortable Wearing Time | 11.5 hours per day | Standard Deviation 2.9 |
Secondary
Average Comfortable Wearing Time
Typical time of day when subject first experiences lens awareness or irritation
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Average Comfortable Wearing Time | 11.4 hours per day | Standard Deviation 3.3 |
| Lotrafilcon B Toric at Dispense | Average Comfortable Wearing Time | 11.0 hours per day | Standard Deviation 3.4 |
Secondary
Average Hours of Wear Per Day
Number of hours lenses are worn per day
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Average Hours of Wear Per Day | 13.8 hours per day | Standard Deviation 3 |
Secondary
Average Hours of Wear Per Day
Number of hours lenses are worn per day
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Toric Lens at Baseline | Average Hours of Wear Per Day | 14.1 hours per day | Standard Deviation 2.9 |
| Lotrafilcon B Toric at Dispense | Average Hours of Wear Per Day | 14.0 hours per day | Standard Deviation 2.6 |