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

Primary Purpose

Dry Eye, Ametropia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Optive ®
Fresh Tears ®
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. 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.

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

Exclusion Criteria:

  1. Any patient with punctual occlusion or punctual plugs.
  2. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,
  3. Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.
  4. Patients with Epiphora.
  5. 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.
  6. 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.

Sites / Locations

  • Department of Ophthalmology, UNIFESP&EPM

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

optive® eye drop

fresh tears ® eye drop

Arm Description

Outcomes

Primary Outcome Measures

patients satisfaction with osmoprotective lubricant on different types DTS.

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2012
Last Updated
February 14, 2017
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01741987
Brief Title
Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients
Official Title
An Effectiveness of Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome (DTS) and Post Refractive Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Ametropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
optive® eye drop
Arm Type
Active Comparator
Arm Title
fresh tears ® eye drop
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Optive ®
Intervention Description
instilation of 1 drop each eye 4 times per day
Intervention Type
Other
Intervention Name(s)
Fresh Tears ®
Intervention Description
instilation of eye drop 4 times a day (qid)
Primary Outcome Measure Information:
Title
patients satisfaction with osmoprotective lubricant on different types DTS.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.
Time Frame
3 months
Title
Physician satisfaction with Optive®
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients.
Time Frame
3 monthas
Title
change from baseline in Ocular Surface Disease Index (OSDI)
Time Frame
3 moths
Title
change from baseline in tear break up time (BUT)
Time Frame
3 mothas
Title
change from baseline in lissamine green staining
Time Frame
3 months
Title
change form baseline in impression cytology
Time Frame
3 months
Title
change from baseline in tear osmolarity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rossen M Hazarbassanov, MD
Organizational Affiliation
Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, UNIFESP&EPM
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/eyediseases.html
Description
eye diseases
URL
http://clinicaltrials.gov/ct2/info/fdalinks
Description
FDA Resources on Drugs and Devices

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

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