Residence Time Evaluation of Marketed OTC Ophthalmic Products

NCT00804791 | Completed

• 1 other identifier: M-08-11
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dry Eye

Keywords

dry eye; autofluorescence; residence time

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Systane

ACTIVE COMPARATOR

One drop dispensed into each eye

Other: Systane Ultra Lubricant Eye Drops

Unisol

ACTIVE COMPARATOR

One drop dispensed into each eye

Other: Unisol 4 Saline Solution

Interventions

Systane Ultra Lubricant Eye Drops OTHER

artificial tears solution for lubricating the cornea

Systane

Unisol 4 Saline Solution OTHER

saline solution for irrigating the cornea

Unisol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Last Updated: February 2, 2012

Record last verified: 2012-01