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Safety and Efficacy of PG101 for Dry Eye Syndrome (PG101)

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PG101

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Keratoconjunctivitis sicca, Dry eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be male or female of any race, at least 18 years of age
Have provided verbal and written informed consent
Be able and willing to follow instructions, including participation in all study assessments and visits
Have a reported history of dry eye syndrome
Have a history of use or desire to use eye drops for dry eye
If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period
Have a best corrected visual acuity of +0.70 logMAR or better in both eyes

Exclusion Criteria:

Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1
Be a woman who is pregnant, nursing or planning a pregnancy
Have a known allergy and/or sensitivity to the test article or its components
Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1

Sites / Locations

Andover Eye

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PG101 0.25%

PG101 1.0%

Placebo

Arm Description

Topical application of drug

Topical application of placebo

Outcomes

Primary Outcome Measures

At least one dry eye ocular symptom

Dry eye ocular symptoms measured are: Ocular discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing.

Secondary Outcome Measures

At least one dry eye ocular sign measure.

Dry eye ocular signs measured are: Corneal and conjunctival staining, tear break up time, OPI 2.0, Schirmer tear test, quality of life, and conjunctival redness

Full Information

NCT ID

NCT02078661

First Posted

December 20, 2013

Last Updated

March 3, 2014

Sponsor

Rhodes Pharmaceuticals, L.P.

Collaborators

ORA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02078661

Brief Title

Safety and Efficacy of PG101 for Dry Eye Syndrome

Acronym

PG101

Official Title

A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhodes Pharmaceuticals, L.P.

Collaborators

ORA, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

Detailed Description

The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

Keratoconjunctivitis sicca, Dry eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PG101 0.25%

Arm Type

Active Comparator

Arm Description

Topical application of drug

Arm Title

PG101 1.0%

Arm Type

Active Comparator

Arm Description

Topical application of drug

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Topical application of placebo

Intervention Type

Drug

Intervention Name(s)

PG101

Other Intervention Name(s)

Topical gel, Topical gel suspension

Intervention Description

A topical gel containing either 1% or 0.25% PG101 active.

Primary Outcome Measure Information:

Title

At least one dry eye ocular symptom

Description

Dry eye ocular symptoms measured are: Ocular discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing.

Time Frame

Up to 2 weeks

Secondary Outcome Measure Information:

Title

At least one dry eye ocular sign measure.

Description

Dry eye ocular signs measured are: Corneal and conjunctival staining, tear break up time, OPI 2.0, Schirmer tear test, quality of life, and conjunctival redness

Time Frame

Up to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be male or female of any race, at least 18 years of age Have provided verbal and written informed consent Be able and willing to follow instructions, including participation in all study assessments and visits Have a reported history of dry eye syndrome Have a history of use or desire to use eye drops for dry eye If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period Have a best corrected visual acuity of +0.70 logMAR or better in both eyes Exclusion Criteria: Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1 Be a woman who is pregnant, nursing or planning a pregnancy Have a known allergy and/or sensitivity to the test article or its components Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail Torkildsen, M.D.

Organizational Affiliation

Andover Eye

Official's Role

Principal Investigator

Facility Information:

Facility Name

Andover Eye

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

12. IPD Sharing Statement

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Safety and Efficacy of PG101 for Dry Eye Syndrome

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