Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199510
• Other study ID #: SMA-09-05
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2010
• Last updated: November 17, 2016
• Start date: September 2010
• Est. completion date: June 2011

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be at least 18 years of age

• Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation

Exclusion Criteria:

• Patients for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.

• Patients cannot have a history of hypersensitivity to any component of FID 112903.

• Patients cannot have previous intraocular or corneal surgery or any planned within 30 days.

• Patients cannot use any ocular medications other than test article and standard of care post-op medications in past 14 days or during study.

• Patients cannot be on chronic systemic corticosteroid or other immunosuppressive therapy.

• Patients cannot have a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative Intraocular pressure >25 millimeters mercury in either eye.

• Patients cannot have a history and/or current evidence of the following: clinically significant corneal scarring, blepharitis or macular pathology in either eye, Herpes zoster or Herpes simplex keratitis.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Dry Eye

Intervention

Other:
• FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively
• Standard of Care
Post Cataract Surgery Standard of Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

References & Publications (1)

http://www.escrs.org/abstracts/details.asp?confid=9&sessid=372&type=free&paperid=14295

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Comfort	Ocular comfort will be reported by the patient on a questionnaire	30 days	No