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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781092
• Other study ID #: SUSE-01
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: September 19, 2012
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2012
• Source: Durrie Vision
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Systane Ultra
Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
• Bausch and Lomb Sensitive Eyes
Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Durrie Vision	Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear osmolarity		2 week, 1 month	No
Secondary	Tear Break Up Time		2 week, 1 month post op	No

External Links

•   Durrie Vision Research