Trial Outcomes & Findings for Effect of an Investigational Multi-Purpose Solution on Lens Moisture (NCT NCT01341990)

Results Overview

Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

Day 1, 8 hours

Results posted on

2012-04-13

Participant Flow

Participants were recruited from 1 US study center.

Participant milestones

Participant milestones
Measure	FID 114675A Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	ReNu MultiPlus Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Overall Study STARTED	35	33
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	FID 114675A Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	ReNu MultiPlus Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Overall Study Adverse Event	0	1
Overall Study Torn Study Lens	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Effect of an Investigational Multi-Purpose Solution on Lens Moisture

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FID 114675A n=35 Participants Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	ReNu MultiPlus n=33 Participants Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Total n=68 Participants Total of all reporting groups
Age Continuous	43.9 years STANDARD_DEVIATION 9.2 • n=5 Participants	42.8 years STANDARD_DEVIATION 11.2 • n=7 Participants	43.4 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	33 participants n=7 Participants	68 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, 8 hours

Population: Intent to Treat.

Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.

Outcome measures

Outcome measures
Measure	FID 114675A n=34 Participants Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	ReNu MultiPlus n=32 Participants Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Mean Ex-Vivo Advancing Contact Angle	56.7 Degrees Standard Deviation 21.2	59.2 Degrees Standard Deviation 23.7

PRIMARY outcome

Timeframe: Day 8, 16 hours

Population: Intent to treat.

Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.

Outcome measures

Outcome measures
Measure	FID 114675A n=31 Participants Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	ReNu MultiPlus n=32 Participants Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Mean Ex-Vivo Advancing Contact Angle	59.5 Degrees Standard Deviation 21.2	63.4 Degrees Standard Deviation 17.5

Adverse Events

FID 114675A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ReNu MultiPlus

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

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place