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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01199510
Other study ID # SMA-09-05
Secondary ID
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


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
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