An Evaluation of the Safety and Efficacy of FID 114657

Alcon Research153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

153

Conditions

Dry Eye

Interventions

FID 114657OTHER

1 drop both eyes four times a day for 6 weeks

Soothe XP Lubricant Eye DropsOTHER

1 drop both eyes four times a day for 6 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tear Break-Up Time (TBUT)

Time frame: measured at Days 0, 7, 14, 28 and 42

Corneal Staining

Time frame: measured at Days 0, 7, 14, 28 and 42

Conjunctival Staining

Time frame: measured at Days 0, 7, 14, 28 and 42

Data from ClinicalTrials.gov

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