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A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by (Responsible Party):
Daniel S. Durrie, MD, Durrie Vision
ClinicalTrials.gov Identifier:
NCT00781092
First received: October 27, 2008
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Dry Eye
 Other: Systane Ultra
Other: Bausch and Lomb Sensitive Eyes
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Durrie Vision:

Primary Outcome Measures:
  • Tear osmolarity [ Time Frame: 2 week, 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tear Break Up Time [ Time Frame: 2 week, 1 month post op ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Systane Ultra
 Other: Systane Ultra
Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
Other Name: Natural Tears
Active Comparator: 2
Bausch and Lomb Sensitive Eyes
 Other: Bausch and Lomb Sensitive Eyes
Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK
Other Name: Saline Solution

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781092

Sponsors and Collaborators
Durrie Vision
Alcon Laboratories
Investigators
Principal Investigator: Daniel S. Durrie, MD Durrie Vision
  More Information

Additional Information:
Durrie Vision Research  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Daniel S. Durrie, MD, President, Durrie Vision
ClinicalTrials.gov Identifier: NCT00781092     History of Changes
Other Study ID Numbers: SUSE-01
Study First Received: October 27, 2008
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Durrie Vision:
Dry Eyes
LASIK
Laser Vision Correction

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 22, 2013