Trial Outcomes & Findings for Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses (NCT NCT02185105)

NCT ID: NCT02185105

Last Updated: 2017-03-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 15min & 6hrs
• Results posted on: 2017-03-07

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric n=30 Participants 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.
Age, Customized <=18 years	0 participants n=5 Participants
Age, Customized Between 18 and 65 years	30 participants n=5 Participants
Age, Customized >=65 years	0 participants n=5 Participants
Age, Continuous	25 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 15min & 6hrs

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

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Lens Surface Assessment of Study Lenses - Surface Wettability 15 minutes	3.4 units on a scale Standard Deviation 0.3	3.4 units on a scale Standard Deviation 0.2	—
Lens Surface Assessment of Study Lenses - Surface Wettability 6 hours	3.4 units on a scale Standard Deviation 0.4	3.4 units on a scale Standard Deviation 0.4	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Lens Surface Assessment of Study Lenses - Deposits 15 minutes	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	—
Lens Surface Assessment of Study Lenses - Deposits 6 hours	0.03 units on a scale Standard Deviation 0.18	0.00 units on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: 15min & 6hrs

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

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Lens Surface Assessment of Study Lenses - Surface Acceptance 15 minutes	3.4 units on a scale Standard Deviation 0.4	3.4 units on a scale Standard Deviation 0.4	—
Lens Surface Assessment of Study Lenses - Surface Acceptance 6 hours	3.4 units on a scale Standard Deviation 0.5	3.4 units on a scale Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Subjective Rating For Comfort - Comfort Since Last Visit 15 minutes	88 units on a scale Standard Deviation 11	90 units on a scale Standard Deviation 10	—
Subjective Rating For Comfort - Comfort Since Last Visit 3 hours	84 units on a scale Standard Deviation 17	87 units on a scale Standard Deviation 12	—
Subjective Rating For Comfort - Comfort Since Last Visit 6 hours	84 units on a scale Standard Deviation 15	88 units on a scale Standard Deviation 11	—

PRIMARY outcome

Timeframe: 1min, 15min, 3hrs, 6hrs

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

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference n=30 Participants
Subjective Rating For Comfort Preference 1 minute	23 percentage of subjects	47 percentage of subjects	30 percentage of subjects
Subjective Rating For Comfort Preference 15 minutes	23 percentage of subjects	47 percentage of subjects	30 percentage of subjects
Subjective Rating For Comfort Preference 3 hours	17 percentage of subjects	30 percentage of subjects	53 percentage of subjects
Subjective Rating For Comfort Preference 6 hours	20 percentage of subjects	37 percentage of subjects	43 percentage of subjects

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Subjective Rating For Handling - Insertion	95 units on a scale Standard Deviation 7	95 units on a scale Standard Deviation 7	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Subjective Rating For Handling - Removal	63 units on a scale Standard Deviation 38	74 units on a scale Standard Deviation 30	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Investigator's Assessment of Stability 15 minutes	3 degrees Standard Deviation 4	3 degrees Standard Deviation 3	—
Investigator's Assessment of Stability 6 hours	3 degrees Standard Deviation 3	4 degrees Standard Deviation 7	—

PRIMARY outcome

Timeframe: 15min & 6hrs

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

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
General Lens Fit - Fit Acceptance 6 hours	3.4 units on a scale Standard Deviation 0.2	3.4 units on a scale Standard Deviation 0.2	—
General Lens Fit - Fit Acceptance 15 minutes	3.4 units on a scale Standard Deviation 0.2	3.4 units on a scale Standard Deviation 0.2	—

PRIMARY outcome

Timeframe: 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=(-).

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Lens Fitting - Rotation/Mislocation Baseline	1 degrees Standard Deviation 5	3 degrees Standard Deviation 9	—
Lens Fitting - Rotation/Mislocation 15 minutes	1 degrees Standard Deviation 6	1 degrees Standard Deviation 7	—
Lens Fitting - Rotation/Mislocation 6 hours	2 degrees Standard Deviation 5	-1 degrees Standard Deviation 7	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Corneal Staining (Central) Baseline	0.02 units on a scale Standard Deviation 0.09	0.02 units on a scale Standard Deviation 0.09	—
Anterior Ocular Health - Corneal Staining (Central) 6 hours	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Corneal Staining (Nasal) Baseline	0.02 units on a scale Standard Deviation 0.09	0.05 units on a scale Standard Deviation 0.20	—
Anterior Ocular Health - Corneal Staining (Nasal) 6 hours	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Corneal Staining (Temporal) Baseline	0.02 units on a scale Standard Deviation 0.09	0.05 units on a scale Standard Deviation 0.20	—
Anterior Ocular Health - Corneal Staining (Temporal) 6 hours	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - CornealStaining (Superior) Baseline	0.00 units on a scale Standard Deviation 0.00	0.03 units on a scale Standard Deviation 0.18	—
Anterior Ocular Health - CornealStaining (Superior) 6 hours	0.02 units on a scale Standard Deviation 0.09	0.00 units on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Corneal Staining (Inferior) Baseline	0.12 units on a scale Standard Deviation 0.31	0.05 units on a scale Standard Deviation 0.20	—
Anterior Ocular Health - Corneal Staining (Inferior) 6 hours	0.13 units on a scale Standard Deviation 0.35	0.28 units on a scale Standard Deviation 0.45	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Conjunctival Staining (Nasal) Baseline	0.20 units on a scale Standard Deviation 0.41	0.13 units on a scale Standard Deviation 0.35	—
Anterior Ocular Health - Conjunctival Staining (Nasal) 6 hours	0.20 units on a scale Standard Deviation 0.41	0.23 units on a scale Standard Deviation 0.43	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Conjunctival Staining (Superior) Baseline	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	—
Anterior Ocular Health - Conjunctival Staining (Superior) 6 hours	0.00 units on a scale Standard Deviation 0.00	0.03 units on a scale Standard Deviation 0.18	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Conjunctival Staining (Temporal) Baseline	0.07 units on a scale Standard Deviation 0.25	0.00 units on a scale Standard Deviation 0.00	—
Anterior Ocular Health - Conjunctival Staining (Temporal) 6 hours	0.07 units on a scale Standard Deviation 0.25	0.13 units on a scale Standard Deviation 0.35	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Comfilcon A XR (Extended Range) Toric n=30 Participants 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.	Comfilcon A Toric n=30 Participants Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.	No Preference
Anterior Ocular Health - Conjunctival Staining (Inferior) Baseline	0.03 units on a scale Standard Deviation 0.18	0.00 units on a scale Standard Deviation 0.00	—
Anterior Ocular Health - Conjunctival Staining (Inferior) 6 hours	0.10 units on a scale Standard Deviation 0.31	0.10 units on a scale Standard Deviation 0.31	—

Adverse Events

Comfilcon A MTO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sr. Manager, Clinical Research

CooperVision, Inc

Phone: 9257306754

Email: pchamberlain@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
• Publication restrictions are in place

Restriction type: OTHER