Residence Time Evaluation of Marketed OTC Ophthalmic Products

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804791
• Other study ID #: M-08-11
• Status: Completed
• Phase: N/A
• First received: December 5, 2008
• Last updated: January 31, 2012
• Start date: November 2008

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

The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent and HIPAA read, signed and dated before conducting any procedures.

• Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system).

• Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.

Exclusion Criteria:

• History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.

• History or evidence of serious ocular trauma in either eye w/i the past 6 months.

• History of intolerance or hypersensitivity to any component of the study medications.

• History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.

• Use of concomitant topical ocular medications during the study period.

• Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.

• Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.

• Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1.

• Participation in an investigational drug or device study w/i 30 days of entering this study.

• Additionally, any subject may be declared ineligible for a valid medical reason.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• Systane Ultra Lubricant Eye Drops
artificial tears solution for lubricating the cornea
• Unisol 4 Saline Solution
saline solution for irrigating the cornea

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Residence Time	Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.	After 8 minutes, then every 2 minutes	No