Trial Outcomes & Findings for Longitudinal Evaluation of Silicone Hydrogel (LASH) Study (NCT NCT00727402)

NCT ID: NCT00727402

Last Updated: 2012-02-15

Results Overview

Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.

• Recruitment status: COMPLETED
• Target enrollment: 205 participants
• Primary outcome timeframe: annual
• Results posted on: 2012-02-15

Participant Flow

Participant milestones

Measure	Observational healthy patients fit into lotrafilcon A contact lenses for continuous wear
Overall Study STARTED	205
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	116

Reasons for withdrawal

Measure	Observational healthy patients fit into lotrafilcon A contact lenses for continuous wear
Overall Study Physician Decision	116

Baseline Characteristics

Longitudinal Evaluation of Silicone Hydrogel (LASH) Study

Baseline characteristics by cohort

Measure	Observational n=205 Participants healthy patients fit into lotrafilcon A contact lenses for continuous wear
Age Continuous	32.8 years STANDARD_DEVIATION 5 • n=93 Participants
Age, Customized <=21 years	26 participants n=93 Participants
Age, Customized Between 21 and 50 years	163 participants n=93 Participants
Age, Customized >50 years	16 participants n=93 Participants
Sex: Female, Male Female	157 Participants n=93 Participants
Sex: Female, Male Male	48 Participants n=93 Participants
Region of Enrollment United States	205 participants n=93 Participants

PRIMARY outcome

Timeframe: annual

Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.

Outcome measures

Measure	Observational n=410 eyes healthy patients fit into lotrafilcon A contact lenses for continuous wear
Cumulative Incidence of Corneal Inflammatory Events	26.7 annual incidence per 100 subjects Interval 20.1 to 35.0

Adverse Events

Observational

Serious events: 0 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Observational n=205 participants at risk healthy patients fit into lotrafilcon A contact lenses for continuous wear
Eye disorders corneal inflammatory event	18.5% 38/205 • Number of events 44
Eye disorders Other non-Corneal Inflammatory Event	9.8% 20/205

Additional Information

Loretta Szczotka-Flynn OD, PhD

Case Western Reserve University Dept Ophthalmology & Visual Sciences

Phone: 216-844-3609

Email: loretta.szczotka@uhhospitals.org

Results disclosure agreements

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