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

Sponsor

Durrie Vision (Other)

Overall Status

Completed

CT.gov ID

NCT00781092

Collaborator

Alcon Research (Industry)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: Systane Ultra Other: Bausch and Lomb Sensitive Eyes	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Tear osmolarity [2 week, 1 month]

Secondary Outcome Measures

Tear Break Up Time [2 week, 1 month post op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.