Trial Outcomes & Findings for Clear Care® Plus vs. PeroxiClear™ (NCT NCT02413333)

Results Overview

The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

133 participants

Primary outcome timeframe

Day 30, each product

Results posted on

2016-09-19

Participant Flow

Participants were recruited from ten investigational centers located in the United States.

All randomized participants (132). One enrolled participant discontinued prior to randomization.

Participant milestones

Participant milestones
Measure	Clear Care Plus, Then PeroxiClear Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.	PeroxiClear, Then Clear Care Plus PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
Period 1 STARTED	66	66
Period 1 Randomized and Treated	66	66
Period 1 COMPLETED	65	65
Period 1 NOT COMPLETED	1	1
Period 2 STARTED	65	65
Period 2 COMPLETED	64	65
Period 2 NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Clear Care Plus, Then PeroxiClear Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.	PeroxiClear, Then Clear Care Plus PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
Period 1 Adverse Event	1	0
Period 1 Reason Not Specified	0	1
Period 2 Protocol Deviation	1	0

Baseline Characteristics

Clear Care® Plus vs. PeroxiClear™

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clear Care Plus, Then PeroxiClear n=65 Participants Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.	PeroxiClear, Then Clear Care Plus n=65 Participants PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.	Clear Care Plus, Then Clear Care Plus n=1 Participants Clear Care Plus was used in Period 1 and in Period 2.	PeroxiClear, Then PeroxiClear n=1 Participants PeroxiClear was used in Period 1 and in Period 2.	Total n=132 Participants Total of all reporting groups
Age, Continuous	37.7 years STANDARD_DEVIATION 11.2 • n=99 Participants	35.7 years STANDARD_DEVIATION 11.8 • n=107 Participants	42.0 years STANDARD_DEVIATION NA • n=206 Participants	38.0 years STANDARD_DEVIATION NA • n=7 Participants	36.7 years STANDARD_DEVIATION 11.4 • n=31 Participants
Age, Customized 18-64 years	65 participants n=99 Participants	64 participants n=107 Participants	1 participants n=206 Participants	1 participants n=7 Participants	131 participants n=31 Participants
Age, Customized ≥65 years	0 participants n=99 Participants	1 participants n=107 Participants	0 participants n=206 Participants	0 participants n=7 Participants	1 participants n=31 Participants
Sex: Female, Male Female	52 Participants n=99 Participants	49 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	103 Participants n=31 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	16 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	29 Participants n=31 Participants

PRIMARY outcome

Timeframe: Day 30, each product

Population: Intention to treat participants with non-missing observations

The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).

Outcome measures

Outcome measures
Measure	PeroxiClear n=130 Lens Cases PeroxiClear Lens Cases	Clear Care Plus n=130 Lens Cases Clear Care Plus Lens Cases
Mean Residual Peroxide at Day 30	229.7 parts per million (ppm) Standard Deviation 280.13	26.2 parts per million (ppm) Standard Deviation 41.17

SECONDARY outcome

Timeframe: Day 30, each product

Population: Intention to treat participants with non-missing observations

The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).

Outcome measures

Outcome measures
Measure	PeroxiClear n=130 Lens Cases PeroxiClear Lens Cases	Clear Care Plus n=130 Lens Cases Clear Care Plus Lens Cases
Mean Osmolality in Lens Cases at Day 30	345.1 milliosmoles/kg (mOsm/kg) Standard Deviation 11.76	299.2 milliosmoles/kg (mOsm/kg) Standard Deviation 7.63

Adverse Events

PeroxiClear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clear Care Plus

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

Global Medical Affairs Franchise Head, Vision Care

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER