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

NCT00781092 | Completed Phase 4

• 1 other identifier: SUSE-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye

Keywords

Dry Eyes; LASIK; Laser Vision Correction

Outcome Measures

Primary Outcomes (1)

• Tear osmolarity

  2 week, 1 month

Secondary Outcomes (1)

• Tear Break Up Time

  2 week, 1 month post op

Study Arms (2)

1

EXPERIMENTAL

Systane Ultra

Other: Systane Ultra

2

ACTIVE COMPARATOR

Bausch and Lomb Sensitive Eyes

Other: Bausch and Lomb Sensitive Eyes

Interventions

Systane Ultra OTHER

Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative

Also known as: Natural Tears

1

Bausch and Lomb Sensitive Eyes OTHER

Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK

Also known as: Saline Solution

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Durrie Vision: lead
• Alcon Research: collaborator

Related Links

• Durrie Vision Research

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Daniel S. Durrie, MD

  Durrie Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 20, 2012

Record last verified: 2012-09