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Safety and Efficacy of PG101 for Dry Eye Syndrome

Sponsor
Rhodes Pharmaceuticals, L.P. (Industry)
Overall Status
Completed
CT.gov ID
NCT02078661
Collaborator
ORA, Inc. (Industry)
72
Enrollment
1
Location
3
Arms
1
Duration (Months)
70.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PG101 0.25%

Topical application of drug

Drug: PG101
A topical gel containing either 1% or 0.25% PG101 active.
Other Names:
  • Topical gel
  • Topical gel suspension

    		•
    Active Comparator: PG101 1.0%

    Topical application of drug

    Drug: PG101
    A topical gel containing either 1% or 0.25% PG101 active.
    Other Names:
  • Topical gel
  • Topical gel suspension

    		•
    Placebo Comparator: Placebo

    Topical application of placebo

    Drug: PG101
    A topical gel containing either 1% or 0.25% PG101 active.
    Other Names:
  • Topical gel
  • Topical gel suspension

    		•

    Outcome Measures

    Primary Outcome Measures

    1. At least one dry eye ocular symptom [Up to 2 weeks]

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

    Secondary Outcome Measures

    1. At least one dry eye ocular sign measure. [Up to 2 weeks]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andover Eye Andover Massachusetts United States 01810

    Sponsors and Collaborators

    • Rhodes Pharmaceuticals, L.P.
    • ORA, Inc.

    Investigators

    • Principal Investigator: Gail Torkildsen, M.D., Andover Eye

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rhodes Pharmaceuticals, L.P.
    ClinicalTrials.gov Identifier:
    NCT02078661
    Other Study ID Numbers:
    • RP-PG-EF001
    • 13-110-0002
    First Posted:
    Mar 5, 2014
    Last Update Posted:
    Mar 5, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Rhodes Pharmaceuticals, L.P.
    Keratoconjunctivitis sicca
    Dry eye
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Syndrome

    Study Results

    No Results Posted as of Mar 5, 2014