Residence Time Evaluation of Marketed OTC Ophthalmic Products

NCT ID: NCT00804791

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Systane

One drop dispensed into each eye

Group Type: ACTIVE_COMPARATOR

Systane Ultra Lubricant Eye Drops

Intervention Type: OTHER

artificial tears solution for lubricating the cornea

Unisol

One drop dispensed into each eye

Group Type: ACTIVE_COMPARATOR

Unisol 4 Saline Solution

Intervention Type: OTHER

saline solution for irrigating the cornea

Interventions

Systane Ultra Lubricant Eye Drops

artificial tears solution for lubricating the cornea

Intervention Type: OTHER

Unisol 4 Saline Solution

saline solution for irrigating the cornea

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

M-08-11

Identifier Type: -

Identifier Source: org_study_id