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

Not Applicable

Completed

• Conditions: Dry Eye; Ametropia
• Interventions: Other: Optive ®; Other: Fresh Tears ®

• Registration Number: NCT01741987
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2012-10
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Study Completion: 2015-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fresh tears ® eye drop	Optive ®	-
optive® eye drop	Fresh Tears ®	-

Primary Outcome Measures

Name	Time	Method
patients satisfaction with osmoprotective lubricant on different types DTS.	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology, UNIFESP&EPM; 🇧🇷 Sao Paulo, SP, Brazil