Chronic Allergic ConjunctivitisPhase 4NCT01730872

Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

A Phase 4 study testing Prednisolone Sodium Phosphate Ophthalmic Solution 1% and Tears Naturale II Ophthalmic Solution in people with Chronic 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

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: Chronic Allergic Inflammation… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Allergic Conjunctivitis
What is being tested?: Prednisolone Sodium Phosphate Ophthalmic Solution 1% and Tears Naturale II Ophthalmic Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Dec 2012
Phase: Phase 4
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

At least 18 years of age \& either sex, any race
Willing and able to follow all instructions
Positive history of ocular allergies
Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Who cannot join

Have planned surgery during trial period
Female currently pregnant, planning a pregnancy or lactating
Use of disallowed medications
Have ocular infections, or ocular conditions that could affect study parameters
Have moderate to severe dry eye
Have used an investigational drug or device within 30 days of start of study
Female that is currently pregnant, planning a pregnancy or lactating

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, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Read the detailed description

Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.

Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 2 weeks

Controls:

Artificial Tears (Tears Naturale® II)

Conditions: Chronic Allergic Conjunctivitis
Being tested: Prednisolone Sodium Phosphate Ophthalmic Solution 1%, Tears Naturale II Ophthalmic Solution

What participants receive

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

Prednisolone Sodium Phosphate Ophthalmic Solution 1%Drug
One drop in each eye, four times/day for 4 days.
Tears Naturale II Ophthalmic SolutionDrug
one drop in each eye, four times/ day (QID) for 4 days

Study groups in NCT01730872
Study group	Role	What they receive
Prednisolone	Experimental	Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Receives: Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Placebo	Placebo comparator	Tears Naturale II Ophthalmic Solution, 1% Receives: Drug: Tears Naturale II Ophthalmic Solution

What is being measured

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

Inflammation Change From Baseline to Day 6
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
Measured: 90 minutes post CAC

Secondary outcomes (2)

Ocular Itching Change From Baseline to Day 6
Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
Measured: 7 minutes post-CAC
Ocular Redness Change From Baseline to Day 6
Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).
Measured: 7 minutes post-CAC

Timeline

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

Nov 2012Dec 2012

First posted21 Nov 2012 (estimated)
Study startNov 2012
Primary completionDec 2012
Study completionDec 2012

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 Chronic 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01730872
Sponsor's protocol ID: 12-270-0007
Status last verified: Jun 2019
First submitted: 15 Nov 2012
Last updated: 19 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model
ClinicalTrials.gov ID: NCT01730872
Acronym / sponsor ID: 12-270-0007
Conditions: Chronic Allergic Conjunctivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: ORA, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 21 Nov 2012 (estimated)
Results: Posted 19 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Detailed description

Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 2 weeks

Controls:

Artificial Tears (Tears Naturale® II)

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Prednisolone	Experimental	Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Placebo	Placebo comparator	Drug: Tears Naturale II Ophthalmic SolutionTears Naturale II Ophthalmic Solution, 1%

Who may qualify

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

Key inclusion criteria (4 listed)

At least 18 years of age \& either sex, any race
Willing and able to follow all instructions
Positive history of ocular allergies
Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Key exclusion criteria (7 listed)

Have planned surgery during trial period
Female currently pregnant, planning a pregnancy or lactating
Use of disallowed medications
Have ocular infections, or ocular conditions that could affect study parameters
Have moderate to severe dry eye

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
Prednisolone Sodium Phosphate Ophthalmic Solution 1%One drop in each eye, four times/day for 4 days.	Drug	Prednisolone
Tears Naturale II Ophthalmic Solutionone drop in each eye, four times/ day (QID) for 4 days	Drug	Placebo

Primary outcome

Inflammation Change From Baseline to Day 6
Time frame: 90 minutes post CAC
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).

2 secondary outcomes

Ocular Itching Change From Baseline to Day 6
Time frame: 7 minutes post-CAC
Ocular Redness Change From Baseline to Day 6
Time frame: 7 minutes post-CAC

Results and safety

Results posted to the registry on 19 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prednisolone	8	8
Placebo	5	5
Control	3	3

Primary outcome: Inflammation Change From Baseline to Day 6

Time frame: 90 minutes post CAC. Mean (Standard Deviation). Unit: score on a scale

Measure	Prednisolone n = 8	Placebo n = 4
Value	-1.2 (0.78)	-0.19 (0.43)

Population analysed: The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prednisolone	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Placebo	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Saline	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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, MD principal investigator

Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology

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

Questions about this trial

What is this clinical trial studying?

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 7 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 19 Jun 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 19 Jun 2019). 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?

Inflammation Change From Baseline to Day 6 (time frame: 90 minutes post CAC). 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 NCT01730872.

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 19 Jun 2019.