Trial Outcomes & Findings for Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS) (NCT NCT00733291)

Results Overview

Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

After 2 hours of wear

Results posted on

2011-12-28

Participant Flow

64 subjects currently wearing hydrogel or silicone hydrogel lenses on a daily wear schedule for at least two weeks were enrolled between 1/7/08 and 2/1/08 by 4 US optometry sites

18 hours of no contact lens wear (glasses only) served as the wash out before Period 1. This reporting group includes all enrolled and dispensed participants as treated.

Participant milestones

Participant milestones
Measure	Nelfilcon A Soak / Nelfilcon A no Soak Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.	Nelfilcon A no Soak / Nelfilcon A Soak Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.	Etafilcon A Soak / Etafilcon A no Soak Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.	Etafilcon A no Soak / Etafilcon Soak Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
First Intervention, 2 Hrs (+/- 30 Min) STARTED	13	17	17	17
First Intervention, 2 Hrs (+/- 30 Min) COMPLETED	13	17	17	17
First Intervention, 2 Hrs (+/- 30 Min) NOT COMPLETED	0	0	0	0
Washout Period, 3 Days (+/-1 Day) STARTED	13	17	17	17
Washout Period, 3 Days (+/-1 Day) COMPLETED	12	17	17	17
Washout Period, 3 Days (+/-1 Day) NOT COMPLETED	1	0	0	0
Second Intervention, 2 Hrs (+/- 30 Min) STARTED	12	17	17	17
Second Intervention, 2 Hrs (+/- 30 Min) COMPLETED	12	17	17	17
Second Intervention, 2 Hrs (+/- 30 Min) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfilcon A Soak / Nelfilcon A no Soak Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.	Nelfilcon A no Soak / Nelfilcon A Soak Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.	Etafilcon A Soak / Etafilcon A no Soak Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.	Etafilcon A no Soak / Etafilcon Soak Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
Washout Period, 3 Days (+/-1 Day) Failed inc criteria Second Intervention	1	0	0	0

Baseline Characteristics

Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nelfilcon A Contact Lens n=29 Participants Commercially marketed, single vision, soft contact lens for daily disposable wear	Etafilcon A Contact Lens n=34 Participants Commercially marketed, single vision, soft contact lens for daily disposable wear	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	37.59 years STANDARD_DEVIATION 13.90 • n=5 Participants	38.56 years STANDARD_DEVIATION 12.42 • n=7 Participants	38.11 years STANDARD_DEVIATION 13.02 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	25 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 2 hours of wear

Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.

Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.

Outcome measures

Outcome measures
Measure	Nelfilcon A / FID 107027 n=29 Participants Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Nelfilcon A / no Soak n=29 Participants Nelfilcon A contact lenses inserted directly out of the blister package	Etafilcon A / FID 107027 n=34 Participants Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Etafilcon A / no Soak n=34 Participants Etafilcon A contact lenses inserted directly out of the blister package
Average Corneal Staining Area	0.27 Percentage area of cornea Standard Deviation 0.39	0.08 Percentage area of cornea Standard Deviation 0.13	0.34 Percentage area of cornea Standard Deviation 0.63	0.18 Percentage area of cornea Standard Deviation 0.25

PRIMARY outcome

Timeframe: After 2 hours of wear

Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.

Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed.

Outcome measures

Outcome measures
Measure	Nelfilcon A / FID 107027 n=29 Participants Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Nelfilcon A / no Soak n=29 Participants Nelfilcon A contact lenses inserted directly out of the blister package	Etafilcon A / FID 107027 n=34 Participants Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Etafilcon A / no Soak n=34 Participants Etafilcon A contact lenses inserted directly out of the blister package
Total Corneal Staining Type	1.59 Units on a scale Standard Deviation 1.43	0.79 Units on a scale Standard Deviation 1.18	1.32 Units on a scale Standard Deviation 1.80	1.00 Units on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: After 2 hours of wear

Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.

Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes feel..." with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable.

Outcome measures

Outcome measures
Measure	Nelfilcon A / FID 107027 n=29 Participants Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Nelfilcon A / no Soak n=29 Participants Nelfilcon A contact lenses inserted directly out of the blister package	Etafilcon A / FID 107027 n=34 Participants Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Etafilcon A / no Soak n=34 Participants Etafilcon A contact lenses inserted directly out of the blister package
Ocular Comfort	1.86 Units on a scale Standard Deviation 0.92	1.83 Units on a scale Standard Deviation 0.80	1.65 Units on a scale Standard Deviation 0.69	1.88 Units on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: After two hours of wear

Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.

Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes look..." with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red.

Outcome measures

Outcome measures
Measure	Nelfilcon A / FID 107027 n=29 Participants Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Nelfilcon A / no Soak n=29 Participants Nelfilcon A contact lenses inserted directly out of the blister package	Etafilcon A / FID 107027 n=34 Participants Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion	Etafilcon A / no Soak n=34 Participants Etafilcon A contact lenses inserted directly out of the blister package
Ocular Redness	2.07 Units on a scale Standard Deviation 0.46	2.10 Units on a scale Standard Deviation 0.72	2.18 Units on a scale Standard Deviation 0.76	2.06 Units on a scale Standard Deviation 0.69

Adverse Events

Nelfilcon A / FID 107027

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon A / no Soak

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A / FID 107027

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon / no Soak

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

Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study.
Publication restrictions are in place

Restriction type: OTHER