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OpenTrials
Completed

NCT Number: NCT01741987

Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients

The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, UNIFESP&EPM

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.
  • DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:

2.1. Break up time. 2.2. Lissamine green staining. 2.3. OSDI and Patient Symptomatology Questionnaire.

  • The patients, whose are going to be submitted for refractive surgery.

Exclusion criteria

  • Any patient with punctual occlusion or punctual plugs.
  • Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,
  • Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.
  • Patients with Epiphora.
  • Patients must not have participated in any investigational therapeutic drug or device trial within the 30 days prior to their start date for this trial.
  • Any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.

Treatment and study plan

Optive ®

Other

instilation of 1 drop each eye 4 times per day

Fresh Tears ®

Other

instilation of eye drop 4 times a day (qid)

Primary outcomes

  1. patients satisfaction with osmoprotective lubricant on different types DTS.

    Time frame: 3 months

Secondary outcomes

  1. Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.

    Time frame: 3 months

  2. Physician satisfaction with Optive®

    Time frame: 3 months

Other outcomes

  1. Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients.

    Time frame: 3 monthas

  2. change from baseline in Ocular Surface Disease Index (OSDI)

    Time frame: 3 moths

  3. change from baseline in tear break up time (BUT)

    Time frame: 3 mothas

  4. change from baseline in lissamine green staining

    Time frame: 3 months

  5. change form baseline in impression cytology

    Time frame: 3 months

  6. change from baseline in tear osmolarity

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

An Effectiveness of Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome (DTS) and Post Refractive Surgery Patients

Important dates

Study start
2008
Primary completion
2012
Study completion
2015
First posted
Dec 5, 2012
Registry last updated
Feb 16, 2017

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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