- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00781092
A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes
September 19, 2012 updated by: Daniel S. Durrie, MD, Durrie Vision
The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System.
Post operative questionnaires regarding the use of the drops will be compared.
Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must be a suitable candidate for FDA Approved LASIK.
- Subjects must have a stable refraction as documented by previous clinical records.
- Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
- Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
- Subjects must be at least 18 years of age.
- Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.
- Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion Criteria:
- Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
- Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
- Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.
- Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>25 mm Hg in either eye.
- Subjects with macular pathology in either eye.
- Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
- Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Systane Ultra
|
Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
Other Names:
|
ACTIVE_COMPARATOR: 2
Bausch and Lomb Sensitive Eyes
|
Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tear osmolarity
Time Frame: 2 week, 1 month
|
2 week, 1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tear Break Up Time
Time Frame: 2 week, 1 month post op
|
2 week, 1 month post op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
March 1, 2009
Study Completion (ACTUAL)
March 1, 2009
Study Registration Dates
First Submitted
October 27, 2008
First Submitted That Met QC Criteria
October 27, 2008
First Posted (ESTIMATE)
October 28, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 20, 2012
Last Update Submitted That Met QC Criteria
September 19, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUSE-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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