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
Other: Systane Ultra
Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
Other Names:
  • 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 Names:
  • Saline Solution

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

Durrie Vision

Collaborators

Alcon Research

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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