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Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

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ClinicalTrials.gov Identifier: NCT00724412
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
Comparison of two Dry Eye products

Condition or disease Intervention/treatment Phase
Dry Eye Other: Systane Other: Optive Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Systane

Arm Intervention/treatment
Active Comparator: Systane
Systane
Other: Systane
Dry Eye relief eye drops

Active Comparator: Optive
Optive
Other: Optive
Dry Eye relief eye drops




Primary Outcome Measures :
  1. Tear Break-up time [ Time Frame: 42 days ]


Information from the National Library of Medicine

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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:

  • Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.1.
  • Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10.
  • Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7.

Exclusion:

  • Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  • Use of Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1.
  • Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit
  • Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies.
  • Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
  • Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period.
  • Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00724412     History of Changes
Other Study ID Numbers: SMA-07-15
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry Eye
Corneal Staining

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases