At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 289 enrolled
Drug / intervention
lotrafilcon A +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Mucin Balls and Corneal Inflammation Events
In Brief
A Phase 2 clinical trial evaluating lotrafilcon A, comfilcon A, and 2 other interventions for Corneal Inflammation and Corneal Infiltrative Events. Completed, enrolled 289 participants across 3 sites.
Detailed Summary
The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorneal Inflammation, Corneal Infiltrative Events
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedSep 2011
Primary CompletionFeb 2014
TodayJul 2026
First PostedSep 20, 2011
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.8 years ago
Interventions
lotrafilcon Adevice
To be used during run-in phase only.
comfilcon Adevice
To be assigned at randomization at phase 2 only.
balafilcon Adevice
To be assigned at randomization during phase 2 only.
etafilcon Aother
Assigned to Neophytes during Phase I for a 2-week period