Trial Outcomes & Findings for Evaluation of Deposits on Contact Lenses Worn Extended Wear (NCT NCT00725530)

Results Overview

Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

7 days

Results posted on

2012-08-22

Participant Flow

Each site enrolled normal participants (non-depositors) and depositors in approximately a 1:1 ratio, as outlined in the protocol. 54 participants in 3 US sites and 1 UK site were enrolled.

Participants meeting eligibility criteria at the screening visit were enrolled into the study. 48 hours of no lens wear prior to Visit 1 served as the washout period. This reporting group includes all enrolled and dispensed participants.

Participant milestones

Participant milestones
Measure	Balafilcon A / Etafilcon A Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.	Etafilcon A / Balafilcon A Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
First Intervention, 7 Days (+0/-1) STARTED	27	27
First Intervention, 7 Days (+0/-1) COMPLETED	27	27
First Intervention, 7 Days (+0/-1) NOT COMPLETED	0	0
Second Intervention, 7 Days (+0/-1) STARTED	27	27
Second Intervention, 7 Days (+0/-1) COMPLETED	27	27
Second Intervention, 7 Days (+0/-1) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Deposits on Contact Lenses Worn Extended Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=54 Participants This reporting group includes all enrolled and dispensed participants.
Age Continuous	32.35 years STANDARD_DEVIATION 12.71 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: All enrolled participants.

Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both).

Outcome measures

Outcome measures
Measure	Balafilcon A n=54 Participants Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.	Etafilcon A n=54 Participants Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
Front Surface Lens Deposits Deposits graded <2	20 Participants	25 Participants
Front Surface Lens Deposits Deposits graded >1	34 Participants	29 Participants

Adverse Events

Balafilcon A Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A

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: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60