Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

August 25, 2015 updated by: Allergan
This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Parallel-Group Phase:

  • Weigh at least 110 lbs
  • 18 to 45 years old

Paired-Eye Phase:

  • Dry eye disease in both eyes

Exclusion Criteria:

Parallel-Group Phase:

  • Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
  • Has donated blood within 90 days
  • Significant weight change (over 10 lbs) within 60 days
  • Previous use of RESTASIS®

Parallel-Group and Paired-Eye Phases:

  • Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
  • Consumption of alcohol products within 72 hours

Paired-Eye Phase:

  • Previous ocular surgery
  • Use of RESTASIS® within 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cyclosporine ophthalmic emulsion Formulation A (Formulation A)
Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
Drug: cyclosporine ophthalmic emulsion Formulation A
One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3.
Experimental: cyclosporine ophthalmic emulsion Formulation B (Formulation B)
PGP: cyclosporine ophthalmic emulsion Formulation B
Drug: cyclosporine ophthalmic emulsion Formulation B
One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3.
Other: Formulation A and cyclosporine ophthalmic emulsion 0.05%
Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.
Other Names:
  • RESTASIS®
Other: Formulation B and cyclosporine ophthalmic emulsion 0.05%
PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
Drug: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.
Other Names:
  • RESTASIS®
Experimental: Formulation A and Formulation B
PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Time Frame: Day 1
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)
Time Frame: 3 Days
Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).
3 Days
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Time Frame: Day 1
Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192371-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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