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

Federal University of São Paulo

Status: Completed

Conditions: Dry Eye; Ametropia

Treatments: Other: Optive ®; Other: Fresh Tears ®

Study type: Interventional

Funder types: Other

Identifiers

NCT01741987

1346/08

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

optive® eye drop

Active Comparator group

Treatment:

Other: Fresh Tears ®

fresh tears ® eye drop

Placebo Comparator group

Treatment:

Other: Optive ®