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An Evaluation of the Safety and Efficacy of FID 114657

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ClinicalTrials.gov Identifier: NCT01030237
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Other: FID 114657 Other: Soothe XP Lubricant Eye Drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Tear Break-Up Time (TBUT) [ Time Frame: measured at Days 0, 7, 14, 28 and 42 ]
  2. Corneal Staining [ Time Frame: measured at Days 0, 7, 14, 28 and 42 ]
  3. Conjunctival Staining [ Time Frame: measured at Days 0, 7, 14, 28 and 42 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01030237     History of Changes
Other Study ID Numbers: C-07-34
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 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