Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Other: SootheXP Emollient (Lubricant) Eye Drops; Other: ORB Ocular Emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066988

C-09-046

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (minimum age 18) meeting specific criteria for dry eye.

Exclusion criteria

• Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
• History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Right Eye

Other group

Description:

ORB Ocular Emulsion or SootheXP

Treatment:

Other: ORB Ocular Emulsion

Left Eye

Other group

Description:

ORB Ocular Emulsion or SootheXP

Treatment:

Other: SootheXP Emollient (Lubricant) Eye Drops