Keratoconjunctivitis Sicca Clinical Trial
Official title:
Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points
To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis Sicca (KCS). The purpose of this research is to evaluate evaporative parameters and tear film quality when using Systane lubricating eye drops versus saline in the eyes of dry eye patients at pre-instillation and at 30 and 60 minutes post instillation of drop(s).
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 88 Years |
Eligibility |
Inclusion Criteria: Individuals in good health with signs of Keratoconjunctivitis Sicca
are the primary subject population. An ophthalmologist will perform a thorough ocular exam
in order to assess entrance qualification into the clinical trial. Patients with apparent
Aqueous Tear Deficiency (ATD) with or without slit lamp findings of Meibomian lipid
turbidity or difficulty in expression of Meibomian Gland Secretion (MGD) with ocular
surface vital staining consistent with ATD in the absence of concurrent disease including
lid or ocular surface inflammation beyond 1+ bulbar conjunctival injection will be
enrolled. Exclusion Criteria: Patients with active systemic disease or those taking systemic medication that are known to influence AT production will not be considered for this trial. In addition, patients using topical medication who are unable to discontinue them for at least 24 hours prior to baseline evaluation will be excluded as well. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaporametry changes pre and post instillation of test articles in patients with KCS | In Clinic Visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05618730 -
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
|
Phase 1 | |
Completed |
NCT02254265 -
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
|
Phase 2/Phase 3 | |
Completed |
NCT00883649 -
Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye
|
N/A | |
Completed |
NCT00128245 -
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
|
Phase 2 | |
Completed |
NCT00717418 -
Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease
|
N/A | |
Enrolling by invitation |
NCT03436576 -
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
|
Phase 3 | |
Completed |
NCT04147650 -
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
|
Phase 2/Phase 3 | |
Completed |
NCT01733992 -
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
|
Phase 1 | |
Completed |
NCT00987727 -
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
|
Phase 4 | |
Completed |
NCT00788229 -
Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome
|
Phase 2 | |
Completed |
NCT00554879 -
Acupuncture Treatment of Dry Eye
|
N/A | |
Completed |
NCT00407043 -
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
|
Phase 4 | |
Completed |
NCT00001731 -
Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops
|
Phase 2 | |
Recruiting |
NCT03953703 -
Levocarnitine for Dry Eye in Sjogren's Syndrome
|
Phase 2 | |
Withdrawn |
NCT03398018 -
Repository Corticotropin Injection in Keratoconjunctivitis Sicca
|
Phase 4 | |
Recruiting |
NCT02066896 -
Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
|
Phase 3 | |
Completed |
NCT02139033 -
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome
|
Phase 4 | |
Terminated |
NCT01213342 -
Omega-3 Fatty Acid Supplements and Dry Eye
|
N/A | |
Completed |
NCT00201981 -
Study of Rebamipide Eye Drops to Treat Dry Eye
|
Phase 3 | |
Completed |
NCT00201955 -
Study of Rebamipide Eye Drops to Treat Dry Eye
|
Phase 3 |