Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

Alcon

Status and phase: Completed; Phase 4

Conditions: Dry Eye

Treatments: Other: Systane Ultra Lubricant Eye Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01086774

SMA-09-39

Details and patient eligibility

About

Evaluation of the optical effects of Systane Ultra

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 years or more.
2. Subjects must have Tear Break Up Time (TBUT) < 5 seconds
3. Subjects must have a maximum blink interval (MBI) < 10 seconds
4. Subjects must be willing to comply with all study requirements.
5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion criteria

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
3. Subjects with known sensitivity to planned study concomitant medications
4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Systane Ultra

Experimental group

Description:

Systane Ultra Lubricant Eye Drops

Treatment:

Other: Systane Ultra Lubricant Eye Drops