An Evaluation of the Safety and Efficacy of FID 114657

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.

Completed

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FID 114657

Other

1 drop both eyes four times a day for 6 weeks

Soothe XP Lubricant Eye Drops

Other

1 drop both eyes four times a day for 6 weeks

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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
First posted: Dec 11, 2009
Registry last updated: Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed