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

NCT01741987 | Completed DMC

• 1 other identifier: 1346/08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Ametropia

Outcome Measures

Primary Outcomes (1)

• patients satisfaction with osmoprotective lubricant on different types DTS.

  3 months

Secondary Outcomes (2)

• 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 Outcomes (6)

• Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients.

  3 monthas

• change from baseline in Ocular Surface Disease Index (OSDI)

  3 moths

• change from baseline in tear break up time (BUT)

  3 mothas

Study Arms (2)

optive® eye drop

ACTIVE COMPARATOR

Other: Fresh Tears ®

fresh tears ® eye drop

PLACEBO COMPARATOR

Other: Optive ®

Interventions

Optive ® OTHER

instilation of 1 drop each eye 4 times per day

fresh tears ® eye drop

Fresh Tears ® OTHER

instilation of eye drop 4 times a day (qid)

optive® eye drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Department of Ophthalmology, UNIFESP&EPM

São Paulo, São Paulo, Brazil

Location

Related Links

• eye diseases
• FDA Resources on Drugs and Devices

MeSH Terms

Conditions

Dry Eye Syndromes; Refractive Errors

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Rossen M Hazarbassanov, MD

  Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 5, 2012
• Study Start: October 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: August 1, 2015
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

BR (1)