Allergic ConjunctivitisPhase 4NCT00689078

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

A Phase 4 study testing Prednisolone Acetate 1%, Prednisolone Acetate 0.12% and Loteprednol Etabonate 0.2% 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 of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of 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?: Prednisolone Acetate 1%, Prednisolone Acetate 0.12% and Loteprednol Etabonate 0.2%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteUnited States
Study dates: May 2008to Jun 2008
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

Ophthalmic Research Associates
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model

Read the detailed description

Structure:

Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:

Prednisolone Acetate 1% ophthalmic suspension
Prednisolone Acetate 0.12% ophthalmic suspension
Loteprednol Etabonate 0.2% ophthalmic suspension
Tears Naturale® II

Duration:

Approximately four (4) weeks

Controls:

Artificial Tears (Tears Naturale® II)

Conditions: Allergic Conjunctivitis
Being tested: Prednisolone Acetate 1%, Prednisolone Acetate 0.12%, Loteprednol Etabonate 0.2%, Placebo
Keywords: Allergic conjunctivitis
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

Prednisolone Acetate 1%Drug
Also called Pred Forte (Allergan)
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Prednisolone Acetate 0.12%Drug
Also called Pred Mild (Allergan)
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Loteprednol Etabonate 0.2%Drug
Also called Alrex (Bausch & Lomb)
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
PlaceboDrug
Also called Tears Naturale, Artificial tears
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

Study groups in NCT00689078
Study group	Role	What they receive
Pred acetate 1%	Active comparator	Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Receives: Drug: Prednisolone Acetate 1%
Pred acetate .12%	Active comparator	Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Receives: Drug: Prednisolone Acetate 0.12%
Lot Etab 0.2%	Active comparator	Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Receives: Drug: Loteprednol Etabonate 0.2%
Placebo	Placebo comparator	Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Receives: Drug: Placebo

What is being measured

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

Ocular Itching at Baseline (Day 0)
A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, 7 minutes post-CAC
Ocular Itching at Day 6
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, 7 minutes post-CAC
Ocular Itching at Day 7
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, 7 minutes post-CAC
Ocular Itching at Day 27
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, 7 minutes post-CAC
Ocular Itching at Day 28
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, 7 minutes post-CAC
Ocular Redness at Baseline (Day 0)
A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ocular Redness at Day 6
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ocular Redness at Day 7
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ocular Redness at Day 27
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ocular Redness at Day 28
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC

Timeline

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

May 2008Jun 2008

First posted3 Jun 2008 (estimated)
Study startMay 2008
Primary completionJun 2008
Study completionJun 2008

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689078
Sponsor's protocol ID: 08-003-05
Status last verified: Aug 2020
First submitted: 30 May 2008
Last updated: 2 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model
ClinicalTrials.gov ID: NCT00689078
Acronym / sponsor ID: 08-003-05
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: ORA, Inc.Industry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 3 Jun 2008 (estimated)
Results: Posted 15 Nov 2018

Clinical summary

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

Detailed description

Structure:

Prednisolone Acetate 1% ophthalmic suspension
Prednisolone Acetate 0.12% ophthalmic suspension
Loteprednol Etabonate 0.2% ophthalmic suspension
Tears Naturale® II

Duration:

Approximately four (4) weeks

Controls:

Artificial Tears (Tears Naturale® II)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Pred acetate 1%	Active comparator	Drug: Prednisolone Acetate 1%Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Pred acetate .12%	Active comparator	Drug: Prednisolone Acetate 0.12%Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Lot Etab 0.2%	Active comparator	Drug: Loteprednol Etabonate 0.2%Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Placebo	Placebo comparator	Drug: PlaceboTears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

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 Acetate 1%Also: Pred Forte (Allergan)One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.	Drug	Pred acetate 1%
Prednisolone Acetate 0.12%Also: Pred Mild (Allergan)One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.	Drug	Pred acetate .12%
Loteprednol Etabonate 0.2%Also: Alrex (Bausch & Lomb)One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.	Drug	Lot Etab 0.2%
PlaceboAlso: Tears Naturale, Artificial tearsOne drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.	Drug	Placebo

Primary outcome

Ocular Itching at Baseline (Day 0)
Time frame: 3, 5, 7 minutes post-CAC
A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 6
Time frame: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 7
Time frame: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 27
Time frame: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 28
Time frame: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Redness at Baseline (Day 0)
Time frame: 7, 15, 20 minutes post-CAC
A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 6
Time frame: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 7
Time frame: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 27
Time frame: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 28
Time frame: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.

Results and safety

Results posted to the registry on 15 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pred Forte	9	9
Pred Mild	9	7
Alrex	9	8
Tears Naturale	9	8

Primary outcome: Ocular Itching at Baseline (Day 0)

Time frame: 3, 5, 7 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	Pred Forte n = 9	Pred Mild n = 9	Alrex n = 9	Tears Naturale n = 9
3 minutes post-CAC	2.53 (0.507)	3.08 (0.771)	2.61 (0.953)	2.5 (0.781)
5 minutes post-CAC	2.92 (0.661)	3.47 (0.475)	3.06 (0.682)	2.75 (0.612)
7 minutes post-CAC	3.03 (0.734)	3.44 (0.447)	3.08 (0.685)	2.83 (0.612)

Population analysed: Full Analysis Set

Primary outcome: Ocular Itching at Day 6

Time frame: 3, 5, 7 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	Pred Forte n = 9	Pred Mild n = 8	Alrex n = 8	Tears Naturale n = 9
3 minutes post-CAC	2.17 (0.781)	2.19 (1.108)	2.06 (0.904)	2.33 (0.76)
5 minutes post-CAC	2.44 (0.778)	2.59 (0.954)	2.41 (0.963)	2.53 (0.824)
7 minutes post-CAC	2.17 (0.968)	2.72 (0.891)	2.31 (1.007)	2.14 (0.674)

Population analysed: Per Protocol Population (PP)

Primary outcome: Ocular Itching at Day 7

Time frame: 3, 5, 7 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	Pred Forte n = 9	Pred Mild n = 8	Alrex n = 8	Tears Naturale n = 9
3 minutes post-CAC	2.11 (0.858)	2.28 (1.004)	2.09 (1.069)	2.03 (1.064)
5 minutes post-CAC	2.11 (0.894)	2.69 (1.007)	2.03 (0.85)	1.94 (1.108)
7 minutes post-CAC	1.97 (0.956)	2.75 (0.896)	1.88 (0.982)	1.72 (0.93)

Population analysed: Per Protocol Population (PP)

Primary outcome: Ocular Itching at Day 27

Time frame: 3, 5, 7 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	Pred Forte n = 9	Pred Mild n = 8	Alrex n = 8	Tears Naturale n = 8
3 minutes post-CAC	2.14 (1.119)	2.43 (1.231)	1.75 (1.433)	2.03 (0.871)
5 minutes post-CAC	2.17 (1.281)	2.64 (1.189)	2.09 (1.239)	1.84 (0.801)
7 minutes post-CAC	2.03 (1.314)	2.64 (1.189)	2 (1.382)	1.72 (0.807)

Population analysed: Per Protocol Population (PP)

Adverse events

Time frame: Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pred Forte	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Pred Mild	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
Alrex	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Tears Naturale	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 L Torkildsen, MD principal investigator

American board of Ophthalmology

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisolone Acetate 1%, Prednisolone Acetate 0.12% and Loteprednol Etabonate 0.2% 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 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 2 Sep 2020. 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 15 Nov 2018). 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 Baseline (Day 0) (time frame: 3, 5, 7 minutes post-CAC). The study lists 10 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 NCT00689078.

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 2 Sep 2020.