An Evaluation of the Safety and Efficacy of FID 114657

February 1, 2012 updated by: Alcon Research
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FID 114657
Other: FID 114657
1 drop both eyes four times a day for 6 weeks
ACTIVE_COMPARATOR: Soothe XP Lubricant Eye Drops
Other: Soothe XP Lubricant Eye Drops
1 drop both eyes four times a day for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tear Break-Up Time (TBUT)
Time Frame: measured at Days 0, 7, 14, 28 and 42
measured at Days 0, 7, 14, 28 and 42
Corneal Staining
Time Frame: measured at Days 0, 7, 14, 28 and 42
measured at Days 0, 7, 14, 28 and 42
Conjunctival Staining
Time Frame: measured at Days 0, 7, 14, 28 and 42
measured at Days 0, 7, 14, 28 and 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (ESTIMATE)

December 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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