Allergic ConjunctivitisPhase 2NCT03320434

Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis

A Phase 2 study testing PRT-2761 0.5%, PRT-2761 1% and Patanol in people with Allergic Conjunctivitis, run by ORA, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: PRT-2761 0.5%, PRT-2761 1% and Patanol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 13 Oct 2017to 18 Feb 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 at least 18 years old
be willing and able to avoid all disallowed medications and contact lenses
must have a pregnancy test if of childbearing potential
must be able to read an eye chart from 10 feet away

Who cannot join

must not have any allergies to the study medications
must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Trial locations and contacts

1 site in 1 country.

United States1 site

Andover Eye Associates
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model (Ora-CAC®)

To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.

Conditions: Allergic Conjunctivitis
Being tested: PRT-2761 0.5%, PRT-2761 1%, Patanol, Pred-forte, PRT-2761 0%
Medical subject headings: Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRT-2761 0.5%Drug
Six drops in each eye over a 17 day period.
PRT-2761 1%Drug
Six drops in each eye over a 17 day period.
PatanolDrug
Six drops in each eye over a 17 day period.
Pred-forteDrug
Four drops in each eye over a 3 day period.
PRT-2761 0%Drug
Six drops in each eye over a 17 day period.

Study groups in NCT03320434
Study group	Role	What they receive
PRT-2761 0.5%	Experimental	Not described Receives: Drug: PRT-2761 0.5%
PRT-2761 1%	Experimental	Not described Receives: Drug: PRT-2761 1%
Patanol	Active comparator	Not described Receives: Drug: Patanol
Pred-forte	Active comparator	Not described Receives: Drug: Pred-forte
PRT-2761 0%	Placebo comparator	Not described Receives: Drug: PRT-2761 0%

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.
Measured: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.
Measured: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).
The conjunctival redness was averaged across all subjects at each time point.
Measured: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).
The conjunctival redness was averaged across all subjects at each time point.
Measured: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 201718 Feb 2018

First posted25 Oct 2017
Study start13 Oct 2017
Primary completion16 Feb 2018
Study completion18 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Allergic ConjunctivitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03320434
Sponsor's protocol ID: 17-100-0008
Status last verified: Oct 2022
First submitted: 19 Oct 2017
Last updated: 17 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model (Ora-CAC®)
ClinicalTrials.gov ID: NCT03320434
Acronym / sponsor ID: 17-100-0008
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: ORA, Inc.Industry (pharma, biotech, devices)
Study start: 13 Oct 2017 (actual)
Primary completion: 16 Feb 2018 (actual)
Study completion: 18 Feb 2018 (actual)
First posted: 25 Oct 2017 (actual)
Results: Posted 17 Oct 2022

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 efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
PRT-2761 0.5%	Experimental	Drug: PRT-2761 0.5%
PRT-2761 1%	Experimental	Drug: PRT-2761 1%
Patanol	Active comparator	Drug: Patanol
Pred-forte	Active comparator	Drug: Pred-forte
PRT-2761 0%	Placebo comparator	Drug: PRT-2761 0%

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

be at least 18 years old
be willing and able to avoid all disallowed medications and contact lenses
must have a pregnancy test if of childbearing potential
must be able to read an eye chart from 10 feet away

Key exclusion criteria (3 listed)

must not have any allergies to the study medications
must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

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
PRT-2761 0.5%Six drops in each eye over a 17 day period.	Drug	PRT-2761 0.5%
PRT-2761 1%Six drops in each eye over a 17 day period.	Drug	PRT-2761 1%
PatanolSix drops in each eye over a 17 day period.	Drug	Patanol
Pred-forteFour drops in each eye over a 3 day period.	Drug	Pred-forte
PRT-2761 0%Six drops in each eye over a 17 day period.	Drug	PRT-2761 0%

Primary outcome

Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
Time frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
Time frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
Time frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
Time frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.

Results and safety

Results posted to the registry on 17 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRT-2761 0.5%	32	25
PRT-2761 1%	29	23
Patanol	30	28
PRT-2761 0%	29	23

Primary outcome: Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1

Time frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	PRT-2761 0.5% n = 32	PRT-2761 1% n = 29	Patanol n = 30	PRT-2761 0% n = 29
5 minutes post-CAC	2.573 (0.9246)	2.500 (0.7792)	1.217 (0.8826)	2.647 (0.8170)
7 minutes post-CAC	2.677 (0.8879)	2.509 (0.8114)	1.358 (0.8627)	2.629 (0.7459)
10 minutes post-CAC	2.250 (1.0878)	2.293 (1.0135)	1.258 (0.9727)	2.190 (0.8754)

Population analysed: All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.

Primary outcome: Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15

Time frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15. Mean (Standard Deviation). Unit: units on a scale

Measure	PRT-2761 0.5% n = 32	PRT-2761 1% n = 29	Patanol n = 30	PRT-2761 0% n = 29
5 minutes post-CAC	2.431 (1.1415)	2.611 (0.7731)	0.775 (0.7172)	2.527 (0.9288)
7 minutes post-CAC	2.362 (1.0724)	2.602 (0.7883)	0.808 (0.7505)	2.366 (0.9317)
10 minutes post-CAC	1.922 (1.1242)	2.204 (1.0630)	0.833 (0.8077)	1.929 (0.9425)

Primary outcome: Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1

Time frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.. Mean (Standard Deviation). Unit: units on a scale

Measure	PRT-2761 0.5% n = 32	PRT-2761 1% n = 29	Patanol n = 30	PRT-2761 0% n = 29
7 minutes post-CAC	1.282 (0.6479)	1.491 (0.5919)	1.592 (0.7236)	1.957 (0.4913)
15 minutes post-CAC	1.411 (0.6142)	1.526 (0.5989)	1.833 (0.7350)	2.181 (0.3774)
20 minutes post-CAC	1.371 (0.5841)	1.603 (0.6251)	1.917 (0.6833)	2.164 (0.4496)

Primary outcome: Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15

Time frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.. Mean (Standard Deviation). Unit: units on a scale

Measure	PRT-2761 0.5% n = 32	PRT-2761 1% n = 29	Patanol n = 30	PRT-2761 0% n = 29
7 minutes post-CAC	1.723 (0.5787)	2.056 (0.4458)	1.242 (0.7296)	1.973 (0.4731)
15 minutes post-CAC	1.920 (0.6703)	2.176 (0.4894)	1.617 (0.7478)	1.991 (0.5464)
20 minutes post-CAC	1.857 (0.6289)	2.222 (0.6699)	1.592 (0.7266)	2.036 (0.6372)

Population analysed: All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a.

Adverse events

Time frame: Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRT-2761 0.5%	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32
PRT-2761 1%	0 of 29 (0%)	9 of 29 (31%)	0 of 29
Patanol	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30
PRT-2761 0%	0 of 29 (0%)	7 of 29 (24.1%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRT-2761 0.5%, PRT-2761 1% and Patanol in people with Allergic Conjunctivitis, run by ORA, Inc. 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 4 inclusion and 3 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 17 Oct 2022. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 17 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 (time frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03320434.

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 17 Oct 2022.