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Clinical Outcomes Following Treatment With SYSTANE® BALANCE

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Status

Completed

Conditions

Dry Eye

Treatments

Other: Propylene glycol, 0.6% eye drops
Other: Lubricant eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT02776670
EXB107-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.

Enrollment

308 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Willing and able to attend all study visits;
  • Must sign an informed consent form;
  • Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
  • Willing to take study products as directed for entire study;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
  • Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
  • Use of medication excluded by the protocol;
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
  • Ocular surgeries or procedures excluded by the protocol;
  • Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

308 participants in 2 patient groups

SYSTANE BALANCE
Experimental group
Description:
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
Treatment:
Other: Propylene glycol, 0.6% eye drops
REFRESH OPTIVE
Active Comparator group
Description:
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
Treatment:
Other: Lubricant eye drops

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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