An Evaluation of the Safety and Efficacy of FID 114657

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Other: FID 114657; Other: Soothe XP Lubricant Eye Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030237

C-07-34

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of dry eye
• NaFl Corneal Staining sum score ≥ 3 in either eye

Exclusion criteria

• Must not have worn contact lenses for 1 week preceding enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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153 participants in 2 patient groups

FID 114657

Experimental group

Description:

FID 114657

Treatment:

Other: FID 114657

Soothe XP Lubricant Eye Drops

Active Comparator group

Description:

Soothe XP Lubricant Eye Drops

Treatment:

Other: Soothe XP Lubricant Eye Drops