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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741987
• Other study ID #: 1346/08
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: February 14, 2017
• Start date: October 2008
• Est. completion date: August 2015

Study information

• Verified date: February 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ametropia
• Dry Eye
• Refractive Errors

Intervention

Other:
• Optive ®
instilation of 1 drop each eye 4 times per day
• Fresh Tears ®
instilation of eye drop 4 times a day (qid)

Locations

Country	Name	City	State
Brazil	Department of Ophthalmology, UNIFESP&EPM	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients.		3 monthas
Other	change from baseline in Ocular Surface Disease Index (OSDI)		3 moths
Other	change from baseline in tear break up time (BUT)		3 mothas
Other	change from baseline in lissamine green staining		3 months
Other	change form baseline in impression cytology		3 months
Other	change from baseline in tear osmolarity		3 months
Primary	patients satisfaction with osmoprotective lubricant on different types DTS.		3 months
Secondary	Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.		3 months
Secondary	Physician satisfaction with Optive®		3 months

External Links

•   eye diseases
•   FDA Resources on Drugs and Devices