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CompletedNCT02078661PG101Updated Mar 5, 2014

Safety and Efficacy of PG101 for Dry Eye Syndrome

A Phase 1/2 interventional study of PG101 in Dry Eye Syndrome, sponsored by Rhodes Pharmaceuticals, L.P.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-05.

Sponsored by Rhodes Pharmaceuticals, L.P. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Dry Eye Syndrome

Keywords

  • Keratoconjunctivitis sicca
  • Dry eye
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 72 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Rhodes Pharmaceuticals, L.P. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    PG101 0.25%

    Topical application of drug

    Drug: PG101

  • Active comparator
    PG101 1.0%

    Topical application of drug

    Drug: PG101

  • Placebo comparator
    Placebo

    Topical application of placebo

    Drug: PG101

Interventions

  • DrugPG101

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

    Also known as: Topical gel, Topical gel suspension

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 weeks

Secondary outcomes

  1. 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

    Time frame: Up to 2 weeks

07

Study locations

1 site
  • Andover Eye
    Andover, Massachusetts 01810, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02078661
Lead sponsor
Rhodes Pharmaceuticals, L.P.
Collaborators
ORA, Inc.
Responsible party
Sponsor
First posted
Mar 5, 2014
Start date
Dec 2013
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Mar 5, 2014

Study contacts

Gail Torkildsen, M.D.
principal investigator · Andover Eye

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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