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

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ClinicalTrials.gov Identifier: NCT02078661
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.

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
Dry Eye Syndrome Drug: PG101 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

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




Primary Outcome Measures :
  1. At least one dry eye ocular symptom [ Time Frame: 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. [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078661


Locations
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United States, Massachusetts
Andover Eye
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Rhodes Pharmaceuticals, L.P.
ORA, Inc.
Investigators
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Principal Investigator: Gail Torkildsen, M.D. Andover Eye

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Responsible Party: Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier: NCT02078661     History of Changes
Other Study ID Numbers: RP-PG-EF001
13-110-0002 ( Other Identifier: Rhodes Pharmaceuticals L.P. )
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Rhodes Pharmaceuticals, L.P.:
Keratoconjunctivitis sicca
Dry eye

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases