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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

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Systane Ultra

Bausch and Lomb Sensitive Eyes

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry Eyes, LASIK, Laser Vision Correction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Systane Ultra

Bausch and Lomb Sensitive Eyes

Outcomes

Primary Outcome Measures

Tear osmolarity

Secondary Outcome Measures

Tear Break Up Time

Full Information

NCT ID

NCT00781092

First Posted

October 27, 2008

Last Updated

September 19, 2012

Sponsor

Durrie Vision

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00781092

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Durrie Vision

Collaborators

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry Eyes, LASIK, Laser Vision Correction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Systane Ultra

Arm Title

Arm Type

Active Comparator

Arm Description

Bausch and Lomb Sensitive Eyes

Intervention Type

Other

Intervention Name(s)

Systane Ultra

Other Intervention Name(s)

Natural Tears

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Bausch and Lomb Sensitive Eyes

Other Intervention Name(s)

Saline Solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Tear osmolarity

Time Frame

2 week, 1 month

Secondary Outcome Measure Information:

Title

Tear Break Up Time

Time Frame

2 week, 1 month post op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel S. Durrie, MD

Organizational Affiliation

Durrie Vision

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

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

Description

Durrie Vision Research

Learn more about this trial

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

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