Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

NCT02004067 | Completed Phase 4

• 1 other identifier: 17821013.0.0000.5505
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.

Conditions

Primary Sjogren Syndrome; Secondary Sjogren Syndrome; Aqueous Deficient Dry Eye Disease; Evaporative Dry Eye Disease

Keywords

Evaporative; Aqueous deficient; Dry eye disease

Outcome Measures

Primary Outcomes (1)

• Ocular surface inflammation

  3 months

Study Arms (2)

Refresh Endura

ACTIVE COMPARATOR

Topical lubricant containing (glycerin; polysorbate 80; castor oil; carbomer, boric acid, sodium hydroxide, purified water), one drop 2 times a day, for 3 months.

Drug: Refresh Endura

Restasis

EXPERIMENTAL

Topical immunomodulatory lubricant (Ophthalmic emulsion containing cyclosporine 0.5 mg/mL, i.e., 0.05%), one drop 2 times a day, for 3 months

Drug: Restasis

Interventions

Restasis DRUG

Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.

Also known as: Cyclosporine 0.05%

Restasis

Refresh Endura DRUG

Refresh Endura is a topical lubricant produced by Allergan, Inc.

Also known as: Castor oil

Refresh Endura

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed for mild to moderate Aqueous Deficient DED (ADDED), defined as Schirmer 1 \< 10mm;
• Patients diagnosed for mild to moderate Evaporative DED (EDED), defined as normal Schirmer 1 and BUT \< 5 seconds;
• Patients submitted to refractive surgery,
• Patients capable of understanding instructions, signing the term of consent and available to attend all exam visits.

You may not qualify if:

• patients with punctual occlusion,
• active ocular infection or inflammatory disease,
• history of herpetic keratitis,
• contact lens use during trial period,
• patients with glaucoma,
• any eyelid globe malposition abnormality.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Allergan: collaborator

Study Sites (1)

Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP

São Paulo, São Paulo, 04023 062, Brazil

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins; Castor Oil

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Rossen M Hazarbassanov, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 6, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

BR (1)