Trial Outcomes & Findings for In-vivo Wettability Grading and Assessment Study (NCT NCT01010555)

NCT ID: NCT01010555

Last Updated: 2012-07-10

Results Overview

On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 4 weeks of wear
• Results posted on: 2012-07-10

Participant Flow

Four participants were enrolled but not dispensed due to failing inclusion/exclusion criteria (2) and withdrawing consent (2). These participants are included in the Actual Enrollment and Baseline Characteristics calculations, but not Participant Flow.

This reporting group includes all enrolled and dispensed participants.

Participant milestones

Measure	Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.	Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
First Four Weeks of Wear STARTED	11	10
First Four Weeks of Wear COMPLETED	11	10
First Four Weeks of Wear NOT COMPLETED	0	0
Second Four Weeks of Wear STARTED	10	9
Second Four Weeks of Wear COMPLETED	10	9
Second Four Weeks of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In-vivo Wettability Grading and Assessment Study

Baseline characteristics by cohort

Measure	Overall n=25 Participants This reporting group includes all enrolled subjects.
Age Continuous	20.0 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks of wear

Population: Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.

Outcome measures

Measure	Lotrafilcon B n=19 Participants Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.	Balafilcon A n=19 Participants Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.	Senofilcon A n=19 Participants Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.	Enfilcon A n=19 Participants Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
On-eye Wettability	1.33 units on a scale Standard Deviation 1.01	2.11 units on a scale Standard Deviation 1.16	1.70 units on a scale Standard Deviation 1.09	2.07 units on a scale Standard Deviation 1.00

Adverse Events

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Balafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enfilcon 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

Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs

CIBA VISION

Phone: 1-800-241-7629

Email: priya.janakiraman@cibavision.com

Results disclosure agreements

• Principal investigator is a sponsor employee No distribution of trial-specific information without express written permission of Director of Centre for Contact Lens Research.
• Publication restrictions are in place

Restriction type: OTHER