Trial Outcomes & Findings for Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges (NCT NCT02193178)

NCT ID: NCT02193178

Last Updated: 2020-07-29

Results Overview

Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
• Results posted on: 2020-07-29

Participant Flow

Participant milestones

Measure	Overall Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Overall Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Overall Study Lost to Follow-up	1
Overall Study Dry eyes	1

Baseline Characteristics

Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

Baseline characteristics by cohort

Measure	Overall Baseline Characteristics n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

Population: One participant discontinued and therefore data was not included in analysis.

Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.

Outcome measures

Measure	Comfilcon A - Baseline n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Overall Comfort	91 units on a scale Standard Deviation 9	88 units on a scale Standard Deviation 11	80 units on a scale Standard Deviation 16	—

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post

Population: One participant discontinued and therefore data was not included in analysis.

Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.

Outcome measures

Measure	Comfilcon A - Baseline n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Overall Vision	85 units on a scale Standard Deviation 15	80 units on a scale Standard Deviation 18	75 units on a scale Standard Deviation 17	—

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

Population: One participant discontinued and therefore data was not included in analysis.

Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy

Outcome measures

Measure	Comfilcon A - Baseline n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Handling	89 units on a scale Standard Deviation 16	94 units on a scale Standard Deviation 9	88 units on a scale Standard Deviation 25	—

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

Population: One participant discontinued and therefore data was not included in analysis.

Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.

Outcome measures

Measure	Comfilcon A - Baseline n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Overall Satisfaction	92 units on a scale Standard Deviation 9	89 units on a scale Standard Deviation 10	90 units on a scale Standard Deviation 10	—

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

Population: One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.

Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.

Outcome measures

Measure	Comfilcon A - Baseline n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=24 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Lens Fit - Rotation 0 degrees	29 percentage of eyes	21 percentage of eyes	18 percentage of eyes	—
Lens Fit - Rotation <=5 degrees	71 percentage of eyes	64 percentage of eyes	64 percentage of eyes	—
Lens Fit - Rotation <=10 degrees	86 percentage of eyes	89 percentage of eyes	93 percentage of eyes	—
Lens Fit - Rotation <=15 degrees	93 percentage of eyes	93 percentage of eyes	93 percentage of eyes	—
Lens Fit - Rotation >15 degrees	7 percentage of eyes	7 percentage of eyes	7 percentage of eyes	—

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

Population: One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.

Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability

Outcome measures

Measure	Comfilcon A - Baseline n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=24 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Lens Fit - Overall Stability	3.3 units on a scale Standard Deviation 0.8	3.3 units on a scale Standard Deviation 0.6	2.8 units on a scale Standard Deviation 0.7	—

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

Population: One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.

General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)

Outcome measures

Measure	Comfilcon A - Baseline n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=24 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Lens Fit Acceptance	3.5 units on a scale Standard Deviation 0.7	3.3 units on a scale Standard Deviation 0.4	3.0 units on a scale Standard Deviation 0.6	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe

Outcome measures

Measure	Comfilcon A - Baseline n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Anterior Ocular Health - Palpebral Hyperemia and Roughness Palpebral Conjunctival Hyperemia (Superior)	0.48 units on a scale Standard Deviation 0.33	—	0.75 units on a scale Standard Deviation 0.81	—
Anterior Ocular Health - Palpebral Hyperemia and Roughness Palpebral Conjunctival Hyperemia (Inferior)	0.50 units on a scale Standard Deviation 0.35	—	0.71 units on a scale Standard Deviation 0.60	—
Anterior Ocular Health - Palpebral Hyperemia and Roughness Palpebral Conjunctival Papillae (Superior)	0.58 units on a scale Standard Deviation 0.44	—	0.61 units on a scale Standard Deviation 0.46	—
Anterior Ocular Health - Palpebral Hyperemia and Roughness Palpebral Conjunctival Papillae (Inferior)	0.54 units on a scale Standard Deviation 0.37	—	0.64 units on a scale Standard Deviation 0.43	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection

Outcome measures

Measure	Comfilcon A - Baseline n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Anterior Ocular Health - Bulbar and Limbal Redness Bulbar (nasal)	0.67 units on a scale Standard Deviation 0.45	—	1.00 units on a scale Standard Deviation 0.71	—
Anterior Ocular Health - Bulbar and Limbal Redness Bulbar (temporal)	0.67 units on a scale Standard Deviation 0.45	—	1.00 units on a scale Standard Deviation 0.75	—
Anterior Ocular Health - Bulbar and Limbal Redness Bulbar (superior)	0.63 units on a scale Standard Deviation 0.46	—	0.79 units on a scale Standard Deviation 0.76	—
Anterior Ocular Health - Bulbar and Limbal Redness Bulbar (inferior)	0.62 units on a scale Standard Deviation 0.45	—	0.79 units on a scale Standard Deviation 0.76	—
Anterior Ocular Health - Bulbar and Limbal Redness Limbal (nasal)	0.21 units on a scale Standard Deviation 0.38	—	0.71 units on a scale Standard Deviation 1.07	—
Anterior Ocular Health - Bulbar and Limbal Redness Limbal (temporal)	0.21 units on a scale Standard Deviation 0.38	—	0.71 units on a scale Standard Deviation 1.07	—
Anterior Ocular Health - Bulbar and Limbal Redness Limbal (superior)	0.21 units on a scale Standard Deviation 0.38	—	0.80 units on a scale Standard Deviation 1.06	—
Anterior Ocular Health - Bulbar and Limbal Redness Limbal (inferior)	0.19 units on a scale Standard Deviation 0.35	—	0.73 units on a scale Standard Deviation 1.09	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area

Outcome measures

Measure	Comfilcon A - Baseline n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Anterior Ocular Health - Corneal Staining Central	0.00 units on a scale Standard Deviation 0.00	—	0.00 units on a scale Standard Deviation 0.00	—
Anterior Ocular Health - Corneal Staining Nasal	0.04 units on a scale Standard Deviation 0.20	—	0.11 units on a scale Standard Deviation 0.31	—
Anterior Ocular Health - Corneal Staining Temporal	0.00 units on a scale Standard Deviation 0.00	—	0.00 units on a scale Standard Deviation 0.00	—
Anterior Ocular Health - Corneal Staining Superior	0.04 units on a scale Standard Deviation 0.20	—	0.04 units on a scale Standard Deviation 0.19	—
Anterior Ocular Health - Corneal Staining Inferior	0.12 units on a scale Standard Deviation 0.33	—	0.11 units on a scale Standard Deviation 0.31	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe

Outcome measures

Measure	Comfilcon A - Baseline n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=28 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) n=26 eyes Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Anterior Ocular Health - Conjunctival Staining and Indentation Nasal	0.21 units on a scale Standard Deviation 0.40	0.54 units on a scale Standard Deviation 0.49	0.34 units on a scale Standard Deviation 0.51	0.37 units on a scale Standard Deviation 0.52
Anterior Ocular Health - Conjunctival Staining and Indentation Temporal	0.11 units on a scale Standard Deviation 0.31	0.29 units on a scale Standard Deviation 0.51	0.23 units on a scale Standard Deviation 0.40	0.38 units on a scale Standard Deviation 0.50
Anterior Ocular Health - Conjunctival Staining and Indentation Superior	0.00 units on a scale Standard Deviation 0.00	0.15 units on a scale Standard Deviation 0.31	0.07 units on a scale Standard Deviation 0.18	0.02 units on a scale Standard Deviation 0.10
Anterior Ocular Health - Conjunctival Staining and Indentation Inferior	0.13 units on a scale Standard Deviation 0.35	0.19 units on a scale Standard Deviation 0.38	0.18 units on a scale Standard Deviation 0.43	0.21 units on a scale Standard Deviation 0.38

PRIMARY outcome

Timeframe: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

Population: One participant discontinued and therefore data was not included in analysis.

Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.

Outcome measures

Measure	Comfilcon A - Baseline n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Visual Acuity High Contrast High Illumination (monocular)	0.06 LogMAR Standard Deviation 0.08	0.07 LogMAR Standard Deviation 0.14	0.06 LogMAR Standard Deviation 0.14	—
Visual Acuity High Contrast High Illumination (binocular)	0.00 LogMAR Standard Deviation 0.07	-0.03 LogMAR Standard Deviation 0.09	-0.04 LogMAR Standard Deviation 0.09	—
Visual Acuity High Contrast Low Illumination (monocular)	0.20 LogMAR Standard Deviation 0.09	0.23 LogMAR Standard Deviation 0.13	0.19 LogMAR Standard Deviation 0.13	—
Visual Acuity High Contrast Low Illumination (binocular)	0.15 LogMAR Standard Deviation 0.10	0.17 LogMAR Standard Deviation 0.14	0.10 LogMAR Standard Deviation 0.09	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

Outcome measures

Measure	Comfilcon A - Baseline n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Subjective Preference - Comfort comfilcon A lenses	69 percentage of subjects	—	57 percentage of subjects	—
Subjective Preference - Comfort No preference	23 percentage of subjects	—	43 percentage of subjects	—
Subjective Preference - Comfort Habitual lenses	8 percentage of subjects	—	0 percentage of subjects	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

Outcome measures

Measure	Comfilcon A - Baseline n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Preference - Vision comfilcon A XR lenses	46.2 percentage of subjects	—	50.0 percentage of subjects	—
Preference - Vision No preference	15.4 percentage of subjects	—	28.6 percentage of subjects	—
Preference - Vision Habitual lenses	38.5 percentage of subjects	—	21.4 percentage of subjects	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Population: Missing data for handling preference for one participant.

Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

Outcome measures

Measure	Comfilcon A - Baseline n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Preference - Handling Missing	0 percentage of subjects	—	7.1 percentage of subjects	—
Preference - Handling comfilcon A lenses	31 percentage of subjects	—	21.4 percentage of subjects	—
Preference - Handling No preference	54 percentage of subjects	—	64.3 percentage of subjects	—
Preference - Handling Habitual lenses	15 percentage of subjects	—	7.1 percentage of subjects	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

Outcome measures

Measure	Comfilcon A - Baseline n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Overall Preference comfilcon A lenses	46 percentage of subjects	—	50 percentage of subjects	—
Overall Preference No preference	23 percentage of subjects	—	43 percentage of subjects	—
Overall Preference Habitual lenses	31 percentage of subjects	—	7 percentage of subjects	—

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.

Outcome measures

Measure	Comfilcon A - Baseline n=13 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Comfilcon A - 2 Weeks Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Habitual Lenses n=14 Participants Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.	Conjunctival Indentation (2 Weeks) Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Investigator Acceptability Agree	85 percentage of subjects	—	86 percentage of subjects	—
Investigator Acceptability Neither Agree nor Disagree	15 percentage of subjects	—	14 percentage of subjects	—
Investigator Acceptability Disagree	0 percentage of subjects	—	0 percentage of subjects	—

Adverse Events

Comfilcon A Toric XR MTO

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