N/A
N=20
Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT00610480 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears — 0.047; 0.049; 0.031; 0.032 (µl/cm2/min)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1st visit Optive, then 2nd visit Systane (Drug); 1st visit Systane, then 2nd visit Optive (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears |
0.047; 0.049; 0.031; 0.032; 0.052; 0.051 | — |
Summary
The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
Eligibility Criteria
Inclusion Criteria
- Individuals aged 18 and up will be included, where any age over 89 will be recorded as 'greater than 89.'
- Individuals with bilateral eye sight eye correctable to 20/80 or better.
- Individuals in good health with or without Meibomian Gland Dystrophy (MGD) but with Aqueous Tear Deficiency (ATD) with minimal to no ocular surface inflammation on slit lamp examination.
Exclusion Criteria
- Individuals with only one sighted eye or vision not correctable to 20/80 or better in both eyes.
- Individuals with history of punctal plugs or punctal occlusions.
- Individuals with history of keratorefractive as well as ophthalmic disease such as corneal dystrophies, glaucoma, or systemic disease affecting the eye (such as Herpes Zoster).
- Individuals with history of systemic or ocular auto-immune conditions.
- Individuals with active systemic disease or those taking systemic medication that are known to influence AT production will not be considered for this trial.
- Individuals using topical medication who are unable to discontinue them for at least 24 hours prior to baseline evaluation will be excluded as well.
Data sourced from ClinicalTrials.gov (NCT00610480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.