Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724412
• Other study ID #: SMA-07-15
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2008
• Last updated: January 31, 2012
• Start date: April 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Comparison of two Dry Eye products

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Systane
Dry Eye relief eye drops
• Optive
Dry Eye relief eye drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Break-up time		42 days	No