Ametropia, Dry Eye
Conditions
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.
Interventions
OTHEROptive ®
instilation of 1 drop each eye 4 times per day
OTHERFresh Tears ®
instilation of eye drop 4 times a day (qid)
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patients satisfaction with osmoprotective lubricant on different types DTS. | 3 months |
Secondary
| 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
| Measure | Time frame |
|---|---|
| change from baseline in lissamine green staining | 3 months |
| change from baseline in Ocular Surface Disease Index (OSDI) | 3 moths |
| change from baseline in tear osmolarity | 3 months |
| change form baseline in impression cytology | 3 months |
| change from baseline in tear break up time (BUT) | 3 mothas |
| Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients. | 3 monthas |
Countries
Brazil
Outcome results
None listed