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Sponsors and Collaborators: |
Durrie Vision Alcon Laboratories |
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Information provided by: | Durrie Vision |
ClinicalTrials.gov Identifier: | NCT00781092 |
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.
Condition | Intervention | Phase |
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Dry Eye |
Drug: Systane Ultra Drug: Bausch and Lomb Sensitive Eyes |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Systane Ultra
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Drug: Systane Ultra
Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
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2: Active Comparator
Bausch and Lomb Sensitive Eyes
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Drug: Bausch and Lomb Sensitive Eyes
Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Durrie Vision ( Daniel S. Durrie, MD-Investigator ) |
Study ID Numbers: | SUSE-01 |
Study First Received: | October 27, 2008 |
Last Updated: | August 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00781092 History of Changes |
Health Authority: | United States: Institutional Review Board |
Dry Eyes LASIK Laser Vision Correction |