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An Evaluation of the Safety and Efficacy of FID 114657

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01030237
First received: December 10, 2009
Last updated: February 1, 2012
Last verified: February 2012
  Purpose
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.

Condition Intervention
Dry Eye Other: FID 114657 Other: Soothe XP Lubricant Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ]

Enrollment: 153
Study Start Date: November 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FID 114657
FID 114657
Other: FID 114657
1 drop both eyes four times a day for 6 weeks
Active Comparator: Soothe XP Lubricant Eye Drops
Soothe XP Lubricant Eye Drops
Other: Soothe XP Lubricant Eye Drops
1 drop both eyes four times a day for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01030237     History of Changes
Other Study ID Numbers: C-07-34
Study First Received: December 10, 2009
Last Updated: February 1, 2012

Keywords provided by Alcon Research:
Dry eye
artificial tears

Additional relevant MeSH terms:
Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 21, 2017