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OpenTrials
Completed

NCT Number: NCT01051804

Evaluation of the Repeated Usage of Systane Ultra Eyedrop

Comparison of two contact lens solutions.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane Ultra

Other

Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks

Optive lubricant Eye Drops

Other

Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

Primary outcomes

  1. Improvement in objective vision

    Time frame: 4 weeks

Secondary outcomes

  1. Measurement of tear film evaporation

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
First posted
Jan 20, 2010
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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