Trial Outcomes & Findings for A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices (NCT NCT04067050)

NCT ID: NCT04067050

Last Updated: 2021-04-13

Results Overview

Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-04-13

Participant Flow

Participant milestones

Measure	Comfilcon A Asphere Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Habitual Spectacles Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
One Month STARTED	32	29
One Month COMPLETED	28	29
One Month NOT COMPLETED	4	0
Two Month STARTED	22	29
Two Month COMPLETED	20	29
Two Month NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Comfilcon A Asphere Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Habitual Spectacles Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
One Month Lost to Follow-up	4	0
Two Month Lost to Follow-up	1	0
Two Month Adverse Event	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Comfilcon A Asphere n=32 Participants Subjects were randomized to use the study contact lenses for two months.	Habitual Spectacles n=29 Participants Subjects were randomized to wear habitual spectacles for two months.	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=32 Participants	0 Participants n=29 Participants	0 Participants n=61 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants	29 Participants n=29 Participants	61 Participants n=61 Participants
Age, Categorical >=65 years	0 Participants n=32 Participants	0 Participants n=29 Participants	0 Participants n=61 Participants
Age, Continuous	24.4 years STANDARD_DEVIATION 3.9 • n=32 Participants	22.9 years STANDARD_DEVIATION 4.4 • n=29 Participants	23.7 years STANDARD_DEVIATION 4.2 • n=61 Participants
Sex: Female, Male Female	20 Participants n=32 Participants	18 Participants n=29 Participants	38 Participants n=61 Participants
Sex: Female, Male Male	12 Participants n=32 Participants	11 Participants n=29 Participants	23 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	32 participants n=32 Participants	29 participants n=29 Participants	61 participants n=61 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Burning Frequency	0.21 units on a scale Standard Deviation 0.49	0.16 units on a scale Standard Deviation 0.37
Symptom of Burning Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: 1 month

Population: One subject scores was not measured for Habitual spectacles group. Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Burning Frequency	0.29 units on a scale Standard Deviation 0.53	0.11 units on a scale Standard Deviation 0.31
Symptom of Burning Intensity	1.14 units on a scale Standard Deviation 0.38	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: 2 months

Population: Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Burning Frequency	0.17 units on a scale Standard Deviation 0.38	0.00 units on a scale Standard Deviation 0.00
Symptom of Burning Intensity	1.00 units on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Itching Intensity	1.00 units on a scale Standard Deviation 0.00	1.08 units on a scale Standard Deviation 0.29
Symptom of Itching Frequency	0.52 units on a scale Standard Deviation 0.57	0.41 units on a scale Standard Deviation 0.56

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Itching Frequency	0.36 units on a scale Standard Deviation 0.56	0.68 units on a scale Standard Deviation 0.55
Symptom of Itching Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Itching Frequency	0.41 units on a scale Standard Deviation 0.50	0.45 units on a scale Standard Deviation 0.51
Symptom of Itching Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Feeling of Foreign Body Frequency	0.17 units on a scale Standard Deviation 0.38	0.19 units on a scale Standard Deviation 0.40
Symptom of Feeling of Foreign Body Intensity	1.20 units on a scale Standard Deviation 0.45	1.33 units on a scale Standard Deviation 0.52

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Feeling of Foreign Body Frequency	0.11 units on a scale Standard Deviation 0.31	0.75 units on a scale Standard Deviation 0.59
Symptom of Feeling of Foreign Body Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Feeling of Foreign Body Frequency	0.21 units on a scale Standard Deviation 0.41	0.50 units on a scale Standard Deviation 0.61
Symptom of Feeling of Foreign Body Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Tearing Frequency	0.43 units on a scale Standard Deviation 0.63	0.53 units on a scale Standard Deviation 0.51
Symptom of Tearing Intensity	1.18 units on a scale Standard Deviation 0.40	1.06 units on a scale Standard Deviation 0.24

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Tearing Frequency	0.33 units on a scale Standard Deviation 0.48	0.39 units on a scale Standard Deviation 0.57
Symptom of Tearing Intensity	1.10 units on a scale Standard Deviation 0.32	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Tearing Frequency	0.45 units on a scale Standard Deviation 0.57	0.35 units on a scale Standard Deviation 0.49
Symptom of Tearing Intensity	1.08 units on a scale Standard Deviation 0.29	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Excessive Blinking Frequency	0.38 units on a scale Standard Deviation 0.56	0.25 units on a scale Standard Deviation 0.51
Symptom of Excessive Blinking Intensity	1.10 units on a scale Standard Deviation 0.32	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Excessive Blinking Frequency	0.29 units on a scale Standard Deviation 0.53	0.46 units on a scale Standard Deviation 0.51
Symptom of Excessive Blinking Intensity	1.14 units on a scale Standard Deviation 0.38	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Excessive Blinking Frequency	0.17 units on a scale Standard Deviation 0.38	0.35 units on a scale Standard Deviation 0.49
Symptom of Excessive Blinking Intensity	1.20 units on a scale Standard Deviation 0.45	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Eye Redness Frequency	0.21 units on a scale Standard Deviation 0.41	0.28 units on a scale Standard Deviation 0.46
Symptom of Eye Redness Intensity	1.00 units on a scale Standard Deviation 0.00	1.11 units on a scale Standard Deviation 0.33

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Eye Redness Frequency	0.18 units on a scale Standard Deviation 0.39	0.36 units on a scale Standard Deviation 0.56
Symptom of Eye Redness Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Eye Redness Frequency	0.24 units on a scale Standard Deviation 0.44	0.20 units on a scale Standard Deviation 0.41
Symptom of Eye Redness Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Eye Pain Frequency	0.34 units on a scale Standard Deviation 0.61	0.34 units on a scale Standard Deviation 0.55
Symptom of Eye Pain Intensity	1.13 units on a scale Standard Deviation 0.35	1.10 units on a scale Standard Deviation 0.32

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Eye Pain Frequency	0.25 units on a scale Standard Deviation 0.44	0.14 units on a scale Standard Deviation 0.36
Symptom of Eye Pain Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Eye Pain Frequency	0.31 units on a scale Standard Deviation 0.54	0.00 units on a scale Standard Deviation 0.00
Symptom of Eye Pain Intensity	1.00 units on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Heavy Eyelids Frequency	0.45 units on a scale Standard Deviation 0.51	0.56 units on a scale Standard Deviation 0.62
Symptom of Heavy Eyelids Intensity	1.00 units on a scale Standard Deviation 0.00	1.13 units on a scale Standard Deviation 0.34

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Heavy Eyelids Frequency	0.46 units on a scale Standard Deviation 0.58	0.39 units on a scale Standard Deviation 0.50
Symptom of Heavy Eyelids Intensity	1.17 units on a scale Standard Deviation 0.39	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Heavy Eyelids Frequency	0.48 units on a scale Standard Deviation 0.63	0.35 units on a scale Standard Deviation 0.49
Symptom of Heavy Eyelids Intensity	1.08 units on a scale Standard Deviation 0.29	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Dryness Frequency	0.48 units on a scale Standard Deviation 0.51	0.38 units on a scale Standard Deviation 0.55
Symptom of Dryness Intensity	1.00 units on a scale Standard Deviation 0.00	1.18 units on a scale Standard Deviation 0.40

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Dryness Frequency	0.43 units on a scale Standard Deviation 0.50	0.75 units on a scale Standard Deviation 0.70
Symptom of Dryness Intensity	1.00 units on a scale Standard Deviation 0.00	1.06 units on a scale Standard Deviation 0.24

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Dryness Frequency	0.48 units on a scale Standard Deviation 0.57	0.75 units on a scale Standard Deviation 0.55
Symptom of Dryness Intensity	1.15 units on a scale Standard Deviation 0.38	1.07 units on a scale Standard Deviation 0.27

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Blurred Vision Frequency	0.45 units on a scale Standard Deviation 0.51	0.34 units on a scale Standard Deviation 0.48
Symptom of Blurred Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Blurred Vision Frequency	0.25 units on a scale Standard Deviation 0.44	0.54 units on a scale Standard Deviation 0.58
Symptom of Blurred Vision Intensity	1.14 units on a scale Standard Deviation 0.38	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Blurred Vision Frequency	0.28 units on a scale Standard Deviation 0.45	0.35 units on a scale Standard Deviation 0.49
Symptom of Blurred Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Double Vision Frequency	0.07 units on a scale Standard Deviation 0.37	0.06 units on a scale Standard Deviation 0.25
Symptom of Double Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Double Vision Frequency	0.07 units on a scale Standard Deviation 0.26	0.11 units on a scale Standard Deviation 0.31
Symptom of Double Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Double Vision Frequency	0.07 units on a scale Standard Deviation 0.26	0.05 units on a scale Standard Deviation 0.22
Symptom of Double Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Difficulty Focusing For Near Vision Frequency	0.41 units on a scale Standard Deviation 0.57	0.28 units on a scale Standard Deviation 0.46
Symptom of Difficulty Focusing For Near Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.10 units on a scale Standard Deviation 0.32

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Difficulty Focusing For Near Vision Frequency	0.29 units on a scale Standard Deviation 0.46	0.18 units on a scale Standard Deviation 0.39
Symptom of Difficulty Focusing For Near Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Difficulty Focusing For Near Vision Frequency	0.14 units on a scale Standard Deviation 0.35	0.45 units on a scale Standard Deviation 0.51
Symptom of Difficulty Focusing For Near Vision Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Increased Sensitivity to Light Frequency	0.48 units on a scale Standard Deviation 0.63	0.59 units on a scale Standard Deviation 0.67
Symptom of Increased Sensitivity to Light Intensity	1.17 units on a scale Standard Deviation 0.39	1.19 units on a scale Standard Deviation 0.40

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Increased Sensitivity to Light Frequency	0.36 units on a scale Standard Deviation 0.62	0.25 units on a scale Standard Deviation 0.44
Symptom of Increased Sensitivity to Light Intensity	1.13 units on a scale Standard Deviation 0.35	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Increased Sensitivity to Light Frequency	0.24 units on a scale Standard Deviation 0.44	0.10 units on a scale Standard Deviation 0.31
Symptom of Increased Sensitivity to Light Intensity	1.14 units on a scale Standard Deviation 0.38	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Colored Haloes Around Objects Frequency	0.17 units on a scale Standard Deviation 0.47	0.16 units on a scale Standard Deviation 0.45
Symptom of Colored Haloes Around Objects Intensity	1.00 units on a scale Standard Deviation 0.00	1.25 units on a scale Standard Deviation 0.50

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Colored Haloes Around Objects Frequency	0.07 units on a scale Standard Deviation 0.26	0.11 units on a scale Standard Deviation 0.31
Symptom of Colored Haloes Around Objects Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Colored Halos Around Objects Frequency	0.07 units on a scale Standard Deviation 0.26	0.10 units on a scale Standard Deviation 0.31
Symptom of Colored Halos Around Objects Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Feeling That Sight is Worsening Frequency	0.48 units on a scale Standard Deviation 0.51	0.34 units on a scale Standard Deviation 0.60
Symptom of Feeling That Sight is Worsening Intensity	1.07 units on a scale Standard Deviation 0.27	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Feeling That Sight is Worsening Frequency	0.36 units on a scale Standard Deviation 0.49	0.25 units on a scale Standard Deviation 0.44
Symptom of Feeling That Sight is Worsening Intensity	1.10 units on a scale Standard Deviation 0.32	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Feeling That Sight is Worsening Frequency	0.45 units on a scale Standard Deviation 0.63	0.20 units on a scale Standard Deviation 0.41
Symptom of Feeling That Sight is Worsening Intensity	1.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline

Population: Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=32 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Headache Frequency	0.69 units on a scale Standard Deviation 0.60	0.72 units on a scale Standard Deviation 0.63
Symptom of Headache Intensity	1.06 units on a scale Standard Deviation 0.24	1.10 units on a scale Standard Deviation 0.30

PRIMARY outcome

Timeframe: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=28 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=28 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Headache Frequency	0.54 units on a scale Standard Deviation 0.58	0.33 units on a scale Standard Deviation 0.48
Symptom of Headache Intensity	1.14 units on a scale Standard Deviation 0.36	1.22 units on a scale Standard Deviation 0.44

PRIMARY outcome

Timeframe: Two Months

Population: Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Outcome measures

Measure	Habitual Spectacles n=29 Participants Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles	Comfilcon A Asphere n=20 Participants Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens
Symptom of Headache Frequency	0.55 units on a scale Standard Deviation 0.51	0.30 units on a scale Standard Deviation 0.47
Symptom of Headache ntensity	1.13 units on a scale Standard Deviation 0.34	1.00 units on a scale Standard Deviation 0.00

Adverse Events

Comfilcon A Asphere

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Habitual Spectacles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Comfilcon A Asphere n=32 participants at risk Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Habitual Spectacles n=29 participants at risk Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Eye disorders Conjunctivitis	3.1% 1/32 • Number of events 1 • From baseline visit up to two months, a total of two months.	0.00% 0/29 • From baseline visit up to two months, a total of two months.

Additional Information

Jose A. Vega

CooperVision, Inc

Phone: 925-640-2964

Email: javega2@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place