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

An Effectiveness of Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome (DTS) 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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Ametropia
• Intervention / Treatment: Other: Fresh Tears ®; Other: Optive ®

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil
      • Department of Ophthalmology, UNIFESP&EPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: optive® eye drop	Other: Fresh Tears ®; instilation of eye drop 4 times a day (qid)
PLACEBO_COMPARATOR: fresh tears ® eye drop	Other: Optive ®; instilation of 1 drop each eye 4 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
patients satisfaction with osmoprotective lubricant on different types DTS.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.	3 months
Physician satisfaction with Optive®	3 months

Other Outcome Measures

Outcome Measure	Time Frame
Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients.	3 monthas
change from baseline in Ocular Surface Disease Index (OSDI)	3 moths
change from baseline in tear break up time (BUT)	3 mothas
change from baseline in lissamine green staining	3 months
change form baseline in impression cytology	3 months
change from baseline in tear osmolarity	3 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Rossen M Hazarbassanov, MD, Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil

Publications and helpful links

Helpful Links

• eye diseases
• FDA Resources on Drugs and Devices

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (ESTIMATE): December 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 1346/08