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
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Keratoconjunctivitis sicca, Dry eye
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
Sites / Locations
- Andover Eye
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
PG101 0.25%
PG101 1.0%
Placebo
Arm Description
Topical application of drug
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
No
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
No
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
Learn more about this trial
Safety and Efficacy of PG101 for Dry Eye Syndrome
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