Trial Outcomes & Findings for Effect of FID 114675A on Lens Wettability (NCT NCT01342107)

Results Overview

As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

16 hours

Results posted on

2012-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	FID 114675A Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.	Blister Pack Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
Overall Study STARTED	34	32
Overall Study COMPLETED	34	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of FID 114675A on Lens Wettability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FID 114675A n=34 Participants Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.	Blister Pack n=32 Participants Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.	Total n=66 Participants Total of all reporting groups
Age Continuous	36.6 years STANDARD_DEVIATION 10.76 • n=5 Participants	37.3 years STANDARD_DEVIATION 12.34 • n=7 Participants	36.9 years STANDARD_DEVIATION 11.47 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 hours

Population: Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set.

As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.

Outcome measures

Outcome measures
Measure	FID 114675A n=66 Participants Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.	Blister Pack n=66 Participants Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
Lens Wettability	95.5 percentage of lenses Interval 87.3 to 99.1	97.0 percentage of lenses Interval 89.5 to 99.6

Adverse Events

FID 114675A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blister Pack

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 Alcon 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