Trial Outcomes & Findings for Daily Wear Corneal Infiltrative Event Study (NCT NCT00937105)

NCT ID: NCT00937105

Last Updated: 2014-03-10

Results Overview

Raw number of participants in each solution arm developing CIE over 12 month follow-up period

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 218 participants
• Primary outcome timeframe: up to 1 year
• Results posted on: 2014-03-10

Participant Flow

From November 2009 to February 2012, 218 participants were randomized at the University Hospitals Case Medical Center Eye Institute.

Existing soft lens wearers or non contact lens wearers were recruited, no wash out period was required

Participant milestones

Measure	Lotrafilcon A Lenses and Clear Care	Lotrafilcon A Lenses and Renu Multiplus
Overall Study STARTED	109	109
Overall Study COMPLETED	69	70
Overall Study NOT COMPLETED	40	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daily Wear Corneal Infiltrative Event Study

Baseline characteristics by cohort

Measure	Lotrafilcon A and Renu n=109 Participants	Lotrafilcon A and Clear Care n=109 Participants	Total n=218 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	108 Participants n=5 Participants	107 Participants n=7 Participants	215 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	34.9 years STANDARD_DEVIATION 11.5 • n=7 Participants	34.7 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	75 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	109 participants n=7 Participants	218 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 year

Population: This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.

Raw number of participants in each solution arm developing CIE over 12 month follow-up period

Outcome measures

Measure	Lotrafilcon A Lenses and Renu n=109 Participants	Lotrafilcon A Lenses and Clear Care n=109 Participants
Number of Participants Developing a Corneal Inflammatory Event (CIE)	6 participants Interval 88.1 to 96.5	7 participants

SECONDARY outcome

Timeframe: up to 1 year

Population: All participants in which valid lens bioburden data was available

Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses

Outcome measures

Measure	Lotrafilcon A Lenses and Renu n=53 Participants	Lotrafilcon A Lenses and Clear Care n=139 Participants
Number of Participants With CIE Stratified by Microbial Bioburden on Lenses	4 participants Interval 0.49 to 6.156	6 participants

SECONDARY outcome

Timeframe: up to 1 year

Population: Number of participants with valid presumed solution induced corneal staining data in each group

Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones

Outcome measures

Measure	Lotrafilcon A Lenses and Renu n=49 Participants	Lotrafilcon A Lenses and Clear Care n=145 Participants
Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.	2 participants Interval 0.167 to 10.393	8 participants

SECONDARY outcome

Timeframe: up to 1 year

Population: All participants in which valid lens case bioburden data was available

Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora

Outcome measures

Measure	Lotrafilcon A Lenses and Renu n=119 Participants	Lotrafilcon A Lenses and Clear Care n=51 Participants
Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases	5 participants Interval 0.161 to 2.822	3 participants

SECONDARY outcome

Timeframe: up to 1 year

Population: All participants in which valid lens bioburden data was available

Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids

Outcome measures

Measure	Lotrafilcon A Lenses and Renu n=154 Participants	Lotrafilcon A Lenses and Clear Care n=40 Participants
Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins	10 participants Interval 1.1 to 24.7	0 participants

SECONDARY outcome

Timeframe: up to 1 year

Population: All participants in which valid lids bioburden data was available

Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids

Outcome measures

Measure	Lotrafilcon A Lenses and Renu n=84 Participants	Lotrafilcon A Lenses and Clear Care n=110 Participants
Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins	8 participants	2 participants

Adverse Events

Entire Cohort of Lotrafilcon A Users

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Entire Cohort of Lotrafilcon A Users n=218 participants at risk
Eye disorders microbial keratitis	0.46% 1/218 • up to 1 year CIE definitions adopted from the standards as listed in the "Institute for Eye Research/L.V. Prasad Eye Institute (IER/LVPEI) Guide To Corneal Infiltrative Conditions Contact Lens Papillary Conjunctivitis was a clinical diagnosis that required temporary or permanent discontinuation of lens wear due to large papilla upon upper lid eversion

Other adverse events

Measure	Entire Cohort of Lotrafilcon A Users n=218 participants at risk
Eye disorders corneal infiltrative event	5.5% 12/218 • up to 1 year CIE definitions adopted from the standards as listed in the "Institute for Eye Research/L.V. Prasad Eye Institute (IER/LVPEI) Guide To Corneal Infiltrative Conditions Contact Lens Papillary Conjunctivitis was a clinical diagnosis that required temporary or permanent discontinuation of lens wear due to large papilla upon upper lid eversion
Eye disorders Contact Lens Papillary Conjunctivitis	5.0% 11/218 • up to 1 year CIE definitions adopted from the standards as listed in the "Institute for Eye Research/L.V. Prasad Eye Institute (IER/LVPEI) Guide To Corneal Infiltrative Conditions Contact Lens Papillary Conjunctivitis was a clinical diagnosis that required temporary or permanent discontinuation of lens wear due to large papilla upon upper lid eversion

Additional Information

Loretta Szczotka-Flynn OD, PhD

University Hospitals Eye Institute

Phone: 216-844-3609

Email: loretta.szczotka@uhhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60