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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01199510

Enrollment

Registered

2010-09-13

Start date

2010-09-30

Completion date

2011-06-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Surgery, Dry Eye

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.

Interventions

OTHERFID 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

OTHERStandard of Care

Post Cataract Surgery Standard of Care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ocular Comfort	30 days	Ocular comfort will be reported by the patient on a questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026