Conditions: Refractive Error
Keywords: Symptoms of Contact Lens Related Discomfort
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.

Detailed description:

Arms:
arm 1: FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. arm 2: Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.

Interventions: intervention 1: FID 114657 eye drops (10 ml) intervention 2: Saline control eye drops (15 ml) intervention 3: Habitual contact lenses
Intervention descriptions: intervention 1: Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye intervention 2: Saline eye drops (15 ml) intervention 3: Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Protocol document: