Dry Eye SyndromePhase 1/2PG101NCT02078661
Safety and Efficacy of PG101 for Dry Eye Syndrome
A Phase 1/2 study testing PG101 in people with Dry Eye Syndrome, run by Rhodes Pharmaceuticals, L.P. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- PG101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jan 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dry Eye Syndrome
- Being tested
- PG101
- Keywords
- Keratoconjunctivitis sicca, Dry eye
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG101Drug
Also called Topical gel, Topical gel suspension
A topical gel containing either 1% or 0.25% PG101 active.
| Study group | Role | What they receive |
|---|---|---|
| PG101 0.25% | Active comparator | Topical application of drug Receives: Drug: PG101 |
| PG101 1.0% | Active comparator | Topical application of drug Receives: Drug: PG101 |
| Placebo | Placebo comparator | Topical application of placebo Receives: Drug: PG101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, M.D., Principal investigator, Andover Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078661
- Sponsor's protocol ID
- RP-PG-EF001
- Other IDs
- 13-110-0002
- Acronym
- PG101
- Status last verified
- Mar 2014
- First submitted
- 20 Dec 2013
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02078661
- Acronym / sponsor ID
- PG101 / RP-PG-EF001
- Conditions
- Dry Eye Syndrome
- Keywords
- Keratoconjunctivitis sicca, Dry eye
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PG101 0.25% | Active comparator | Drug: PG101Topical application of drug |
| PG101 1.0% | Active comparator | Drug: PG101Topical application of drug |
| Placebo | Placebo comparator | Drug: PG101Topical application of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG101Also: Topical gel, Topical gel suspensionA topical gel containing either 1% or 0.25% PG101 active. | Drug | PG101 0.25%, PG101 1.0%, Placebo |
Primary outcome
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.
1 secondary outcome
At least one dry eye ocular sign measure.
Time frame: Up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Torkildsen, M.D. principal investigator
Andover Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PG101 in people with Dry Eye Syndrome, run by Rhodes Pharmaceuticals, L.P. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least one dry eye ocular symptom (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.