Keratoconjunctivitis SiccaNCT00345241
Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points
A study testing Systane Ocular Drops (OTC) in people with Keratoconjunctivitis Sicca, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- Systane Ocular Drops (OTC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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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.
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Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8866
About this study
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).
Read the detailed description
The goal of this research is to evaluate and compare the effectiveness of Systane® versus saline 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.
Twelve (12) patients will be enrolled in this two-period crossover, randomized study design. During the course of the study, each patient will be treated with each test articles in the clinic at separate visits. Following the informed consent procedure, a general ocular evaluation, including corneal and conjunctival staining, Schirmer testing, evaporometry, and interferometry assessments will be completed to determine baseline tear evaporation rate. This will occur before any test article is administered to the patient.
Qualified patients will be randomized into two treatment groups. After 1 hour, in order to eliminate any residual sodium fluorescein, patients will be administered one drop of Systane® (40 µl) or saline (40 µl) in each eye per randomization assignment. At 30 and 60 minutes following instillation of drop, evaporometry and interferometry measurements will be repeated again. These tests (pre and post instillation of drops) will be performed in order to establish a comparison for later analysis. The estimated time in completing these visits will be 180 minutes per visit. Patients will be asked to return to the clinic after 2 - 14 days for evaluation of the 2nd assigned treatment.
During the interim study periods, patients will be asked to continue their pre-study routine; using their pre-study ocular lubricant or other tear products at the same frequency. Any changes in the frequency of product use during the interim period or any changes in other concomitant medications will be carefully recorded. This is especially important since many prescription products (e.g., Claritan) have significant effects on lacrimal gland physiology.
An effort will be made to schedule all study visits at approximately the same time of day in order to reduce diurnal variability. For the similar reasons, all patients will be asked not to use any lubricants or ocular medications within one hour of their office visits.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- Systane Ocular Drops (OTC), Placebo - Saline Drops
- Keywords
- Blepharitis
- Medical subject headings
- Keratoconjunctivitis Sicca, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane Ocular Drops (OTC)Drug
Placebo - Saline DropsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaporametry changes pre and post instillation of test articles in patients with KCS
Measured: In Clinic Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Harrison D. Cavanagh, M.D., Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345241
- Sponsor's protocol ID
- 012006-021
- Status last verified
- Jun 2008
- First submitted
- 23 Jun 2006
- Last updated
- 23 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points
- ClinicalTrials.gov ID
- NCT00345241
- Acronym / sponsor ID
- 012006-021
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- Blepharitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The goal of this research is to evaluate and compare the effectiveness of Systane® versus saline 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.
Twelve (12) patients will be enrolled in this two-period crossover, randomized study design. During the course of the study, each patient will be treated with each test articles in the clinic at separate visits. Following the informed consent procedure, a general ocular evaluation, including corneal and conjunctival staining, Schirmer testing, evaporometry, and interferometry assessments will be completed to determine baseline tear evaporation rate. This will occur before any test article is administered to the patient.
Qualified patients will be randomized into two treatment groups. After 1 hour, in order to eliminate any residual sodium fluorescein, patients will be administered one drop of Systane® (40 µl) or saline (40 µl) in each eye per randomization assignment. At 30 and 60 minutes following instillation of drop, evaporometry and interferometry measurements will be repeated again. These tests (pre and post instillation of drops) will be performed in order to establish a comparison for later analysis. The estimated time in completing these visits will be 180 minutes per visit. Patients will be asked to return to the clinic after 2 - 14 days for evaluation of the 2nd assigned treatment.
During the interim study periods, patients will be asked to continue their pre-study routine; using their pre-study ocular lubricant or other tear products at the same frequency. Any changes in the frequency of product use during the interim period or any changes in other concomitant medications will be carefully recorded. This is especially important since many prescription products (e.g., Claritan) have significant effects on lacrimal gland physiology.
An effort will be made to schedule all study visits at approximately the same time of day in order to reduce diurnal variability. For the similar reasons, all patients will be asked not to use any lubricants or ocular medications within one hour of their office visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systane Ocular Drops (OTC) | Drug | – |
| Placebo - Saline Drops | Drug | – |
Primary outcome
Evaporametry changes pre and post instillation of test articles in patients with KCS
Time frame: In Clinic Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harrison D. Cavanagh, M.D. principal investigator
University of Texas, Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Ocular Drops (OTC) in people with Keratoconjunctivitis Sicca, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaporametry changes pre and post instillation of test articles in patients with KCS (time frame: In Clinic Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2008.