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Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

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Alcon

Status

Completed

Conditions

Lipid Deficiency
Dry Eye Syndrome

Treatments

Other: Minims® Saline 0.9% eyedrops
Other: SYSTANE® BALANCE eyedrops

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Non-contact lens wearer;
  • Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
  • Lipid deficiency;
  • Best visual acuity of 6/9 or better in each eye;
  • Willingness to adhere to the instructions set in the clinical protocol;
  • Signature of the subject informed consent form;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Use of systemic medication which might produce dry eye side effects;
  • Systemic disease which might produce dry eye side effects;
  • Active or recent ocular inflammation or infection;
  • Use of ocular medication;
  • Significant ocular anomaly;
  • Previous ocular surgery;
  • Previous use of Restasis;
  • Any medical condition that might be prejudicial to the study;
  • Pregnant or lactating;
  • Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

91 participants in 2 patient groups

SYSTANE BALANCE
Experimental group
Description:
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Treatment:
Other: SYSTANE® BALANCE eyedrops
Minims Saline
Active Comparator group
Description:
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Treatment:
Other: Minims® Saline 0.9% eyedrops

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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