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

NCT ID: NCT00781092

Last Updated: 2012-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-03-31

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.

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Systane Ultra

Group Type: EXPERIMENTAL

Systane Ultra

Intervention Type: OTHER

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

2

Bausch and Lomb Sensitive Eyes

Group Type: ACTIVE_COMPARATOR

Bausch and Lomb Sensitive Eyes

Intervention Type: OTHER

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

Interventions

Systane Ultra

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

Intervention Type: OTHER

Bausch and Lomb Sensitive Eyes

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

Intervention Type: OTHER

Other Intervention Names

Natural Tears; Saline Solution

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Durrie Vision

OTHER

Sponsor Role: lead

Responsible Party

Daniel S. Durrie, MD

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S. Durrie, MD

Role: PRINCIPAL_INVESTIGATOR

Durrie Vision

Related Links

http://www.durrievision.com/index.cfm/research

Durrie Vision Research

Other Identifiers

SUSE-01

Identifier Type: -

Identifier Source: org_study_id