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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye, Ametropia

Intervention / Treatment
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* Other: Optive ®
* Other: Fresh Tears ®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. The patients, whose are going to be submitted for refractive surgery. Exclusion Criteria: Any patient with punctual occlusion or punctual plugs. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period, Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality. Patients with Epiphora. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: optive® eye drop<br> | Other: Fresh Tears ®<br>* instilation of eye drop 4 times a day (qid)<br>|
| Placebo Comparator: fresh tears ® eye drop<br> | Other: Optive ®<br>* instilation of 1 drop each eye 4 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients satisfaction with osmoprotective lubricant on different types DTS. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |