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Evaluation of the Repeated Usage of Systane Ultra Eyedrop

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Alcon

Status and phase

Completed
Phase 4

Conditions

Dry Eye

Treatments

Other: Optive lubricant Eye Drops
Other: Systane Ultra

Study type

Interventional

Funder types

Industry

Identifiers

NCT01051804
SMA-09-33

Details and patient eligibility

About

Comparison of two contact lens solutions.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 years or more.

  • Non contact lens wearer.

  • Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:

    • Score ≥13 for OSDI Questionnaire total score; AND
    • Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
  • 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.

Exclusion criteria

  • Use of systemic medication which might produce dry eye side effects.
  • Systemic disease which might produce dry eye side effects.
  • Active ocular 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.
  • The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
  • The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
  • The subject, based on their knowledge, must NOT have diabetes.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

57 participants in 2 patient groups

Systane Ultra
Experimental group
Description:
Systane Ultra Lubricant Eye Drops
Treatment:
Other: Systane Ultra
Optive
Active Comparator group
Description:
Optive Lubricant Eye Drops
Treatment:
Other: Optive lubricant Eye Drops

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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