Clinical trial NCT01629706: Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers
Official title: Determination of Cell Population in SICS and Symptomatic Versus Asymptomatic Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2012-06-28
Enrollment: 92
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed description: This study consisted of 2 phases. In Phase 1, participants wore contact lenses pre-soaked overnight in contact lens solution for 2 hours and 4 hours, separate days. A minimum of 7 days separated the wear periods. Ocular surface cells were collected after both wear periods. In Phase 2, participants wore their habitual contact lenses on a daily wear basis for 4 weeks with habitual lens care. Ocular surface cells were collected after Day 1 and Day 28. Phase 2 included eligible participants who completed Phase 1 and new participants. A participant was considered to be asymptomatic if he/she can typically wear contact lenses comfortably for at least 10 hours/day a minimum of 5 days/week, and symptomatic if he/she typically wears contact lenses for a minimum of 3 days/week and experiences ocular discomfort after less than 6 hours of wear. Phase 1 participants not eligible to participate in Phase 2 or uninterested in continuing into Phase 2 were exited from the study.

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.

Primary outcomes:
measure: Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1
timeFrame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
measure: Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1
timeFrame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
measure: Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1
timeFrame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
measure: 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
timeFrame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
measure: Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1
timeFrame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
measure: Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2
timeFrame: Day 1 and Week 4
measure: Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2
timeFrame: Day 1 and Week 4
measure: Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2
timeFrame: Day 1 and Week 4
measure: Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2
timeFrame: Day 1 and Week 4
measure: 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
timeFrame: Day 1 and Week 4
measure: Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2
timeFrame: Day 1 and Week 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Waterloo School of Optometry and Vision Science
name: Lyndon Jones, FCOptom, PhD
role: PRINCIPAL_INVESTIGATOR
References: