Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining

Alcon

Status: Completed

Conditions: Corneal Staining

Treatments: Device: Opti-Free RepleniSH; Device: Balafilcon A; Device: ReNu MultiPlus; Other: Unisol 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT01100424

SMA-09-20

Details and patient eligibility

About

The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.

Enrollment: 60 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For non-lens wearers:

• Normal eyes.
• Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
• Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
• Other protocol-defined inclusion criteria may apply.

For contact lens wearers:

• Currently wearing soft contact lenses.
• Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
• Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
• Reports only occasional use of contact lens rewetting drops or artificial tears.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

For non-lens wearers and contact lens wearers:

• Pregnant.
• Participating in another research study.
• Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Contact lens wearers

Experimental group

Description:

Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.

Treatment:

Other: Unisol 4

Device: Opti-Free RepleniSH

Device: ReNu MultiPlus

Device: Balafilcon A

Non-lens wearers

No Intervention group

Description:

Non-lens wearers completed one study visit and served as the control group.