Residence Time Evaluation of Marketed OTC Ophthalmic Products
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00804791
First received: December 5, 2008
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.
| Condition | Intervention |
|---|---|
|
Dry Eye |
Other: Systane Ultra Lubricant Eye Drops Other: Unisol 4 Saline Solution |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Ocular Surface Residence Time [ Time Frame: After 8 minutes, then every 2 minutes ] [ Designated as safety issue: No ]Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.
| Enrollment: | 25 |
| Study Start Date: | November 2008 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Systane
One drop dispensed into each eye
|
Other: Systane Ultra Lubricant Eye Drops
artificial tears solution for lubricating the cornea
Other Name: Systane Ultra Lubricant Eye Drops
|
|
Active Comparator: Unisol
One drop dispensed into each eye
|
Other: Unisol 4 Saline Solution
saline solution for irrigating the cornea
Other Name: Unisol 4 Saline Solution
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00804791 History of Changes |
| Other Study ID Numbers: | M-08-11 |
| Study First Received: | December 5, 2008 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
dry eye autofluorescence residence time |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Tetrahydrozoline |
Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013