Clinical trial NCT01741987: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Ametropia
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: patients satisfaction with osmoprotective lubricant on different types DTS.
timeFrame: 3 months
Secondary outcomes:
measure: Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.
timeFrame: 3 months
measure: Physician satisfaction with Optive®
timeFrame: 3 months
Other outcomes:
measure: Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients.
timeFrame: 3 monthas
measure: change from baseline in Ocular Surface Disease Index (OSDI)
timeFrame: 3 moths
measure: change from baseline in tear break up time (BUT)
timeFrame: 3 mothas
measure: change from baseline in lissamine green staining
timeFrame: 3 months
measure: change form baseline in impression cytology
timeFrame: 3 months
measure: change from baseline in tear osmolarity
timeFrame: 3 months
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Ophthalmology, UNIFESP&EPM
state: SP
Study officials:
affiliation: Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil
name: Rossen M Hazarbassanov, MD
role: PRINCIPAL_INVESTIGATOR
References: