Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03835221

Enrollment

Registered

2019-02-08

Start date

2019-01-01

Completion date

2019-07-06

Last updated

2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ametropia

Brief 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.

Interventions

DEVICEmethafilcon A toric contact lenses

Bilateral daily wear of methafilcon A toric contact lenses

DEVICEfanfilcon A toric contact lenses

Bilateral daily wear of fanfilcon A toric contact lenses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Masking description

Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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 - 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. * 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

* 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 * 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 Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	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.
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	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
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	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	Baseline	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	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.
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	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	Baseline	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	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	Baseline	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	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	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).
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	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	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.
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	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

Secondary

Measure	Time frame	Description
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	2 weeks	Average daily wearing time response by the subject
Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses	4 weeks	Average comfortable wearing time - response by the subject
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	2 weeks	Average comfortable wearing time - response by the subject
Average Daily Wearing Time - Methafilcon A Toric Contact Lenses	4 weeks	Average daily wearing time response by the subject

Countries

Mexico

Participant flow

Participants by arm

Arm	Count
Overall Study Total Participants	43
Total	43

Withdrawals & dropouts

Period	Reason	FG000
Methafilcon A	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Overall Study	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	43 Participants	—
Age, Continuous	24.2 years STANDARD_DEVIATION 6.9	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Mexico	43 participants	—
Sex: Female, Male Female	26 Participants	—
Sex: Female, Male Male	17 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 43	0 / 42
other Total, other adverse events	0 / 43	0 / 42
serious Total, serious adverse events	0 / 43	0 / 42

Outcome results

Primary

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.

Time frame: 4 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.47 Degrees	Standard Deviation 1.9

Primary

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.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.71 Degrees	Standard Deviation 1.8

Primary

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.

Time frame: 2 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.71 Degrees	Standard Deviation 1.8

Primary

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.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	2.21 Degrees	Standard Deviation 4

Primary

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.

Time frame: 4 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	1.55 Degrees	Standard Deviation 3.2

Primary

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).

Time frame: Baseline

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Optimal centration	42 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Decentration acceptable	0 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Decentration unacceptable	0 Participants

Primary

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).

Time frame: 4 weeks

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Optimal centration	42 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Decentration acceptable	0 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Decentration unacceptable	0 Participants

Primary

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).

Time frame: 2 weeks

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Optimal centration	42 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Decentration acceptable	0 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Decentration unacceptable	0 Participants

Primary

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).

Time frame: Baseline

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Optimal Centration	40 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Decentration acceptable	3 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Decentration unacceptable	0 Participants

Primary

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).

Time frame: 4 weeks

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Optimal centration	41 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Decentration acceptable	1 Participants
Methafilcon A	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Decentration unacceptable	0 Participants

Primary

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.

Time frame: 2 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	4.0 units on a scale	Standard Deviation 0.2

Primary

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.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	4.0 units on a scale	Standard Deviation 0.2

Primary

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.

Time frame: 4 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	4.0 units on a scale	Standard Deviation 0.2

Primary

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.

Time frame: 4 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	3.8 units on a scale	Standard Deviation 0.4

Primary

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.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Methafilcon A	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	3.8 units on a scale	Standard Deviation 0.4

Primary