Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02185105

Enrollment

Registered

2014-07-09

Start date

2014-06-30

Completion date

2014-06-30

Last updated

2017-03-07

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

Conditions

Astigmatism, Myopia

Brief summary

The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

Detailed description

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Interventions

DEVICEcomfilcon A MTO

Randomized to a test lens in one eye and control lens in the other as a matched pair.

DEVICEcomfilcon A

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Has had a self-reported oculo-visual examination in the last two years. * Is at least 18 years of age and has full legal capacity to volunteer. * Has read and understood the information consent letter. * Is willing and able to follow instructions and maintain the appointment schedule. * Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * Currently wears soft contact lenses. * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination

Exclusion criteria

* Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * 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 Surface Assessment of Study Lenses - Surface Acceptance	15min & 6hrs	Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
Subjective Rating For Comfort - Comfort Since Last Visit	15min, 3hrs, 6hrs	Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
Lens Surface Assessment of Study Lenses - Surface Wettability	15min & 6hrs	Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
Lens Surface Assessment of Study Lenses - Deposits	15min & 6hrs	Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \> 75% of surface)
Subjective Rating For Comfort Preference	1min, 15min, 3hrs, 6hrs	Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
Subjective Rating For Handling - Insertion	1 min	Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
Subjective Rating For Handling - Removal	1 min	Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
Investigator's Assessment of Stability	15min & 6hrs	Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
General Lens Fit - Fit Acceptance	15min & 6hrs	Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
Lens Fitting - Rotation/Mislocation	Baseline, 15min & 6hrs	Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
Anterior Ocular Health - Corneal Staining (Central)	baseline & 6hrs	Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - Corneal Staining (Nasal)	baseline & 6hrs	Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - Corneal Staining (Temporal)	baseline & 6hrs	Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - CornealStaining (Superior)	baseline & 6hrs	Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - Corneal Staining (Inferior)	baseline & 6hrs	Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - Conjunctival Staining (Nasal)	baseline & 6hrs	Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Superior)	baseline & 6hrs	Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Temporal)	baseline & 6hrs	Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Inferior)	baseline & 6hrs	Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.	30
Total	30

Baseline characteristics

Characteristic	Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric
Age, Continuous	25 years STANDARD_DEVIATION 8
Age, Customized <=18 years	0 participants
Age, Customized >=65 years	0 participants
Age, Customized Between 18 and 65 years	30 participants
Region of Enrollment United States	30 participants
Sex: Female, Male Female	21 Participants
Sex: Female, Male Male	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

Primary

Anterior Ocular Health - Conjunctival Staining (Inferior)

Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Inferior)	Baseline	0.03 units on a scale	Standard Deviation 0.18
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Inferior)	6 hours	0.10 units on a scale	Standard Deviation 0.31
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Inferior)	Baseline	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Inferior)	6 hours	0.10 units on a scale	Standard Deviation 0.31

Primary

Anterior Ocular Health - Conjunctival Staining (Nasal)

Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Nasal)	Baseline	0.20 units on a scale	Standard Deviation 0.41
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Nasal)	6 hours	0.20 units on a scale	Standard Deviation 0.41
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Nasal)	Baseline	0.13 units on a scale	Standard Deviation 0.35
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Nasal)	6 hours	0.23 units on a scale	Standard Deviation 0.43

Primary

Anterior Ocular Health - Conjunctival Staining (Superior)

Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Superior)	Baseline	0.00 units on a scale	Standard Deviation 0
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Superior)	6 hours	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Superior)	Baseline	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Superior)	6 hours	0.03 units on a scale	Standard Deviation 0.18

Primary

Anterior Ocular Health - Conjunctival Staining (Temporal)

Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Temporal)	Baseline	0.07 units on a scale	Standard Deviation 0.25
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Conjunctival Staining (Temporal)	6 hours	0.07 units on a scale	Standard Deviation 0.25
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Temporal)	Baseline	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Anterior Ocular Health - Conjunctival Staining (Temporal)	6 hours	0.13 units on a scale	Standard Deviation 0.35

Primary

Anterior Ocular Health - Corneal Staining (Central)

Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Central)	Baseline	0.02 units on a scale	Standard Deviation 0.09
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Central)	6 hours	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Central)	Baseline	0.02 units on a scale	Standard Deviation 0.09
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Central)	6 hours	0.00 units on a scale	Standard Deviation 0

Primary

Anterior Ocular Health - Corneal Staining (Inferior)

Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Inferior)	Baseline	0.12 units on a scale	Standard Deviation 0.31
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Inferior)	6 hours	0.13 units on a scale	Standard Deviation 0.35
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Inferior)	Baseline	0.05 units on a scale	Standard Deviation 0.2
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Inferior)	6 hours	0.28 units on a scale	Standard Deviation 0.45

Primary

Anterior Ocular Health - Corneal Staining (Nasal)

Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Nasal)	Baseline	0.02 units on a scale	Standard Deviation 0.09
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Nasal)	6 hours	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Nasal)	Baseline	0.05 units on a scale	Standard Deviation 0.2
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Nasal)	6 hours	0.00 units on a scale	Standard Deviation 0

Primary

Anterior Ocular Health - CornealStaining (Superior)

Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - CornealStaining (Superior)	Baseline	0.00 units on a scale	Standard Deviation 0
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - CornealStaining (Superior)	6 hours	0.02 units on a scale	Standard Deviation 0.09
Comfilcon A Toric	Anterior Ocular Health - CornealStaining (Superior)	Baseline	0.03 units on a scale	Standard Deviation 0.18
Comfilcon A Toric	Anterior Ocular Health - CornealStaining (Superior)	6 hours	0.00 units on a scale	Standard Deviation 0

Primary

Anterior Ocular Health - Corneal Staining (Temporal)

Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

Time frame: baseline & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Temporal)	Baseline	0.02 units on a scale	Standard Deviation 0.09
Comfilcon A XR (Extended Range) Toric	Anterior Ocular Health - Corneal Staining (Temporal)	6 hours	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Temporal)	Baseline	0.05 units on a scale	Standard Deviation 0.2
Comfilcon A Toric	Anterior Ocular Health - Corneal Staining (Temporal)	6 hours	0.00 units on a scale	Standard Deviation 0

Primary

General Lens Fit - Fit Acceptance

Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)

Time frame: 15min & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	General Lens Fit - Fit Acceptance	15 minutes	3.4 units on a scale	Standard Deviation 0.2
Comfilcon A XR (Extended Range) Toric	General Lens Fit - Fit Acceptance	6 hours	3.4 units on a scale	Standard Deviation 0.2
Comfilcon A Toric	General Lens Fit - Fit Acceptance	15 minutes	3.4 units on a scale	Standard Deviation 0.2
Comfilcon A Toric	General Lens Fit - Fit Acceptance	6 hours	3.4 units on a scale	Standard Deviation 0.2

Primary

Investigator's Assessment of Stability

Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.

Time frame: 15min & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Investigator's Assessment of Stability	15 minutes	3 degrees	Standard Deviation 4
Comfilcon A XR (Extended Range) Toric	Investigator's Assessment of Stability	6 hours	3 degrees	Standard Deviation 3
Comfilcon A Toric	Investigator's Assessment of Stability	15 minutes	3 degrees	Standard Deviation 3
Comfilcon A Toric	Investigator's Assessment of Stability	6 hours	4 degrees	Standard Deviation 7

Primary

Lens Fitting - Rotation/Mislocation

Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).

Time frame: Baseline, 15min & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Lens Fitting - Rotation/Mislocation	Baseline	1 degrees	Standard Deviation 5
Comfilcon A XR (Extended Range) Toric	Lens Fitting - Rotation/Mislocation	15 minutes	1 degrees	Standard Deviation 6
Comfilcon A XR (Extended Range) Toric	Lens Fitting - Rotation/Mislocation	6 hours	2 degrees	Standard Deviation 5
Comfilcon A Toric	Lens Fitting - Rotation/Mislocation	Baseline	3 degrees	Standard Deviation 9
Comfilcon A Toric	Lens Fitting - Rotation/Mislocation	15 minutes	1 degrees	Standard Deviation 7
Comfilcon A Toric	Lens Fitting - Rotation/Mislocation	6 hours	-1 degrees	Standard Deviation 7

Primary

Lens Surface Assessment of Study Lenses - Deposits

Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \> 75% of surface)

Time frame: 15min & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Lens Surface Assessment of Study Lenses - Deposits	15 minutes	0.00 units on a scale	Standard Deviation 0
Comfilcon A XR (Extended Range) Toric	Lens Surface Assessment of Study Lenses - Deposits	6 hours	0.03 units on a scale	Standard Deviation 0.18
Comfilcon A Toric	Lens Surface Assessment of Study Lenses - Deposits	15 minutes	0.00 units on a scale	Standard Deviation 0
Comfilcon A Toric	Lens Surface Assessment of Study Lenses - Deposits	6 hours	0.00 units on a scale	Standard Deviation 0

Primary

Lens Surface Assessment of Study Lenses - Surface Acceptance

Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)

Time frame: 15min & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Lens Surface Assessment of Study Lenses - Surface Acceptance	15 minutes	3.4 units on a scale	Standard Deviation 0.4
Comfilcon A XR (Extended Range) Toric	Lens Surface Assessment of Study Lenses - Surface Acceptance	6 hours	3.4 units on a scale	Standard Deviation 0.5
Comfilcon A Toric	Lens Surface Assessment of Study Lenses - Surface Acceptance	15 minutes	3.4 units on a scale	Standard Deviation 0.4
Comfilcon A Toric	Lens Surface Assessment of Study Lenses - Surface Acceptance	6 hours	3.4 units on a scale	Standard Deviation 0.5

Primary

Lens Surface Assessment of Study Lenses - Surface Wettability

Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)

Time frame: 15min & 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Lens Surface Assessment of Study Lenses - Surface Wettability	15 minutes	3.4 units on a scale	Standard Deviation 0.3
Comfilcon A XR (Extended Range) Toric	Lens Surface Assessment of Study Lenses - Surface Wettability	6 hours	3.4 units on a scale	Standard Deviation 0.4
Comfilcon A Toric	Lens Surface Assessment of Study Lenses - Surface Wettability	15 minutes	3.4 units on a scale	Standard Deviation 0.2
Comfilcon A Toric	Lens Surface Assessment of Study Lenses - Surface Wettability	6 hours	3.4 units on a scale	Standard Deviation 0.4

Primary

Subjective Rating For Comfort - Comfort Since Last Visit

Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)

Time frame: 15min, 3hrs, 6hrs

Arm	Measure	Group	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Comfort - Comfort Since Last Visit	15 minutes	88 units on a scale	Standard Deviation 11
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Comfort - Comfort Since Last Visit	3 hours	84 units on a scale	Standard Deviation 17
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Comfort - Comfort Since Last Visit	6 hours	84 units on a scale	Standard Deviation 15
Comfilcon A Toric	Subjective Rating For Comfort - Comfort Since Last Visit	15 minutes	90 units on a scale	Standard Deviation 10
Comfilcon A Toric	Subjective Rating For Comfort - Comfort Since Last Visit	3 hours	87 units on a scale	Standard Deviation 12
Comfilcon A Toric	Subjective Rating For Comfort - Comfort Since Last Visit	6 hours	88 units on a scale	Standard Deviation 11

Primary

Subjective Rating For Comfort Preference

Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)

Time frame: 1min, 15min, 3hrs, 6hrs

Arm	Measure	Group	Value (NUMBER)
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Comfort Preference	3 hours	17 percentage of subjects
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Comfort Preference	15 minutes	23 percentage of subjects
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Comfort Preference	1 minute	23 percentage of subjects
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Comfort Preference	6 hours	20 percentage of subjects
Comfilcon A Toric	Subjective Rating For Comfort Preference	15 minutes	47 percentage of subjects
Comfilcon A Toric	Subjective Rating For Comfort Preference	1 minute	47 percentage of subjects
Comfilcon A Toric	Subjective Rating For Comfort Preference	6 hours	37 percentage of subjects
Comfilcon A Toric	Subjective Rating For Comfort Preference	3 hours	30 percentage of subjects
No Preference	Subjective Rating For Comfort Preference	1 minute	30 percentage of subjects
No Preference	Subjective Rating For Comfort Preference	6 hours	43 percentage of subjects
No Preference	Subjective Rating For Comfort Preference	3 hours	53 percentage of subjects
No Preference	Subjective Rating For Comfort Preference	15 minutes	30 percentage of subjects

Primary

Subjective Rating For Handling - Insertion

Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)

Time frame: 1 min

Arm	Measure	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Handling - Insertion	95 units on a scale	Standard Deviation 7
Comfilcon A Toric	Subjective Rating For Handling - Insertion	95 units on a scale	Standard Deviation 7

Primary

Subjective Rating For Handling - Removal

Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)

Time frame: 1 min

Arm	Measure	Value (MEAN)	Dispersion
Comfilcon A XR (Extended Range) Toric	Subjective Rating For Handling - Removal	63 units on a scale	Standard Deviation 38
Comfilcon A Toric	Subjective Rating For Handling - Removal	74 units on a scale	Standard Deviation 30

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Anterior Ocular Health - Conjunctival Staining (Inferior)

Anterior Ocular Health - Conjunctival Staining (Nasal)

Anterior Ocular Health - Conjunctival Staining (Superior)

Anterior Ocular Health - Conjunctival Staining (Temporal)

Anterior Ocular Health - Corneal Staining (Central)

Anterior Ocular Health - Corneal Staining (Inferior)

Anterior Ocular Health - Corneal Staining (Nasal)

Anterior Ocular Health - CornealStaining (Superior)

Anterior Ocular Health - Corneal Staining (Temporal)

General Lens Fit - Fit Acceptance

Investigator's Assessment of Stability

Lens Fitting - Rotation/Mislocation

Lens Surface Assessment of Study Lenses - Deposits

Lens Surface Assessment of Study Lenses - Surface Acceptance

Lens Surface Assessment of Study Lenses - Surface Wettability

Subjective Rating For Comfort - Comfort Since Last Visit

Subjective Rating For Comfort Preference

Subjective Rating For Handling - Insertion

Subjective Rating For Handling - Removal