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

NCT01199510 | Completed Phase 4

• 1 other identifier: SMA-09-05
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dry Eye; Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Ocular Comfort

  Ocular comfort will be reported by the patient on a questionnaire

  30 days

Study Arms (2)

Standard of Care plus FID 112903

EXPERIMENTAL

SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily

Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care

Standard of Care only

ACTIVE COMPARATOR

Post Cataract Standard of Care Regimen

Other: Standard of Care

Interventions

FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care OTHER

Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively

Standard of Care plus FID 112903

Standard of Care OTHER

Post Cataract Surgery Standard of Care

Standard of Care only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years of age
• Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

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

  RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 18, 2016

Record last verified: 2012-01