Trial Outcomes & Findings for Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions (NCT NCT01252134)

Results Overview

Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

8 hours

Results posted on

2012-06-11

Participant Flow

Participants were recruited and enrolled from one Canadian study center.

Participant milestones

Participant milestones
Measure	Synergi, Then Biotrue, Then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Synergi, Then OTE, Then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Biotrue, Then OTE, Then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Biotrue, Then Synergi, Then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	OTE, Then Biotrue, Then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	OTE, Then Synergi, Then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
Period 1, 8 Hours STARTED	3	4	3	5	3	4
Period 1, 8 Hours COMPLETED	3	3	2	5	3	4
Period 1, 8 Hours NOT COMPLETED	0	1	1	0	0	0
Period 2, 8 Hours STARTED	3	3	2	5	3	4
Period 2, 8 Hours COMPLETED	3	3	2	5	3	4
Period 2, 8 Hours NOT COMPLETED	0	0	0	0	0	0
Period 3, 8 Hours STARTED	3	3	2	5	3	4
Period 3, 8 Hours COMPLETED	3	3	2	5	3	4
Period 3, 8 Hours NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Synergi, Then Biotrue, Then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Synergi, Then OTE, Then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Biotrue, Then OTE, Then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Biotrue, Then Synergi, Then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	OTE, Then Biotrue, Then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	OTE, Then Synergi, Then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
Period 1, 8 Hours Personal Reasons	0	1	1	0	0	0

Baseline Characteristics

Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=22 Participants All enrolled participants
Age Continuous	24.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Population: This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error.

Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.

Outcome measures

Outcome measures
Measure	Synergi n=19 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Bio-True n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	OTE Elements n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Ex Vivo Contact Angle	104.8 degrees Standard Deviation 2.4	104.9 degrees Standard Deviation 3.7	103.3 degrees Standard Deviation 5.4

SECONDARY outcome

Timeframe: 8 hours

Population: This reporting group includes all participants who completed the study.

Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.

Outcome measures

Outcome measures
Measure	Synergi n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Bio-True n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	OTE Elements n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Subjective Comfort	87.3 Units on a scale Standard Deviation 7.9	87.3 Units on a scale Standard Deviation 10.2	86.4 Units on a scale Standard Deviation 15.0

SECONDARY outcome

Timeframe: 8 hours

Population: This reporting group includes all participants who completed the study.

Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.

Outcome measures

Outcome measures
Measure	Synergi n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Bio-True n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	OTE Elements n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Corneal Staining Type	5.4 Units on a scale Standard Deviation 8.4	8.8 Units on a scale Standard Deviation 8.4	3.0 Units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 8 hours

Population: This reporting group includes all participants who completed the study.

Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.

Outcome measures

Outcome measures
Measure	Synergi n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Bio-True n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	OTE Elements n=20 Participants Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Corneal Staining Extent	0.7 percentage of cornea Standard Deviation 0.8	3.1 percentage of cornea Standard Deviation 3.8	0.9 percentage of cornea Standard Deviation 4.7

Adverse Events

Synergi

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bio-True

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OTE Elements

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 Medical Affairs

Alcon Research, Ltd.

Phone: 888.451.3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER