Trial Outcomes & Findings for Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses (NCT NCT01629693)

NCT ID: NCT01629693

Last Updated: 2014-11-06

Results Overview

Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 398 participants
• Primary outcome timeframe: Baseline, Day 30
• Results posted on: 2014-11-06

Participant Flow

Participants were recruited from 22 sites located in the United States.

Of the 398 enrolled, 17 participants were exited as screen failures. This reporting group includes all participants who provided informed consent, were randomized, and utilized the study lenses (381).

Participant milestones

Measure	Air Optix Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis	Biofinity Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
Overall Study STARTED	193	188
Overall Study COMPLETED	188	178
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Measure	Air Optix Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis	Biofinity Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	2	2
Overall Study Adverse Event	1	0
Overall Study Investigator decision	0	1
Overall Study Poor comfort of study lenses	0	2
Overall Study Subject decision unrelated to AE	0	1

Baseline Characteristics

Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Measure	Air Optix n=193 Participants Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis	Biofinity n=188 Participants Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis	Total n=381 Participants Total of all reporting groups
Age, Continuous	32.7 years STANDARD_DEVIATION 9.1 • n=5 Participants	33.1 years STANDARD_DEVIATION 10.5 • n=7 Participants	32.9 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	143 Participants n=5 Participants	131 Participants n=7 Participants	274 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	57 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 30

Population: This analysis population includes all participants who completed the protocol and had no major protocol violations.

Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.

Outcome measures

Measure	Air Optix n=179 Participants Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis	Biofinity n=168 Participants Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 Baseline	6.1 units on a scale Standard Deviation 2.2	6.3 units on a scale Standard Deviation 2.1
Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 Change from Baseline at Day 30	1.5 units on a scale Standard Deviation 2.8	1.4 units on a scale Standard Deviation 2.7

Adverse Events

Air Optix

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Biofinity

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Air Optix n=193 participants at risk Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis	Biofinity n=188 participants at risk Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
Infections and infestations Acanthamoeba keratitis	0.52% 1/193 • Adverse events (AEs) were collected from 10 Jul 2013 to 20 Nov 2013. AEs were obtained through volunteered and elicited comments from the participants. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants enrolled and exposed to test and control articles.	0.00% 0/188 • Adverse events (AEs) were collected from 10 Jul 2013 to 20 Nov 2013. AEs were obtained through volunteered and elicited comments from the participants. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants enrolled and exposed to test and control articles.
General disorders Chest pain	0.00% 0/193 • Adverse events (AEs) were collected from 10 Jul 2013 to 20 Nov 2013. AEs were obtained through volunteered and elicited comments from the participants. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants enrolled and exposed to test and control articles.	0.53% 1/188 • Adverse events (AEs) were collected from 10 Jul 2013 to 20 Nov 2013. AEs were obtained through volunteered and elicited comments from the participants. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants enrolled and exposed to test and control articles.

Other adverse events

Adverse event data not reported

Additional Information

Jessie Lemp, GMA Affairs Lead

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor 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