N/A N=44 Randomized Triple-blind Basic Science

Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers

Refractive Error · Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT01629706 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 — 15; 20; 18; 22 cells

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Balafilcon A contact lens (Device); Habitual contact lenses (Device); Renu multi-purpose solution (Device); ClearCare (Device); Habitual lens care (Device)
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: All
Sponsor: CIBA VISION
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1	15; 20; 18; 22	—
PRIMARY Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1	654; 799; 597; 896	—
PRIMARY Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1	25; 26; 22; 27	—
PRIMARY Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens After 2 Hours and 4 Hours of Wear, Phase 1	29.7; 32.8; 36.6; 36.0	—
PRIMARY Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1	96.6; 97.2; 95.9; 96.6	—
PRIMARY Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2	58; 81; 52; 70	—
PRIMARY Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2	2712; 3040; 1522; 2183	—
PRIMARY Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2	2769; 3117; 1574; 2253	—
PRIMARY Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2	2769; 3117; 1574; 2253	—
PRIMARY Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2	24.8; 19.5; 26.8; 28.7	—
PRIMARY Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2	97.4; 97.5; 97.0; 96.6	—

Summary

The purpose of the study is to investigate the corneal epithelial cell response associated with lens wear that results in solution-induced corneal staining (Phase1) and to determine the cell appearance in symptomatic and asymptomatic contact lens wearers (Phase 2).

Eligibility Criteria

Inclusion Criteria (Phase 1):

Full legal capacity to volunteer.
Read and sign an informed consent form.
Willing and able to follow instructions and maintain the appointment schedule.
Current or previous contact lens wearer and competent to insert and remove contact lenses.
Up-to-date spectacles.
Other protocol-defined inclusion criteria may apply.

Inclusion Criteria (Phase 2):

Full legal capacity to volunteer.
Read and sign an informed consent form.
Willing and able to follow instructions and maintain the appointment schedule.
Up-to-date spectacles.
Wears single vision silicone hydrogel contact lenses, following a monthly replacement schedule.
Has worn the same lens type for a minimum of 2 months, with the exception of the 2 periods of lens wear for participants who were also in Phase 1.
Has used the same type of cleaning solution for a minimum of 2 months.
Currently wears brand name contact lenses and uses brand name cleaning solutions that are commercially available in Canada (no private labels).
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria (Phase 1 and 2):

Any ocular disease.
Systemic condition that may affect a study outcome variable.
Use of any systemic or topical medications that may affect ocular health.
Known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Presents with significant amounts of corneal staining.
Current use of artificial tears and/or rewetting drops.
Wears contact lenses on an extended (overnight) or continuous wear schedule.
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01629706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.