Allergic ConjunctivitisPhase 2NCT01860664
Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis
A Phase 2 study testing hydrocortisone ophthalmic ointment 0.5% in people with Allergic Conjunctivitis, run by Koffler Vision Group at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment 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?
- hydrocortisone ophthalmic ointment 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 1 Jan 2017
- Phase
- Phase 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
- Diagnosis of allergic conjunctivitis. b) Must be at least 18 years of age c) Must be able and willing to comply with all treatment and follow up procedures d) Best corrected visual acuity of 0.3 logMAR or better (Snellen equivalent score of 20/40 or better) in each eye at Visit 1 e) Conjunctival redness score ≥1.5 in at least one eye at Visit 1 f) Subject reported itching assessment >2.0 in at least 1 eye at Visit 1 g) Mean IOP >8 and <24 in each eye h) If female of childbearing potential, are non-lactating and non-pregnant, and must be willing to use an approved birth control method for the duration of the study, and must have a negative urine pregnancy test. (Urine pregnancy test will be conducted at Visit 1 after subject completes Informed Consent Document prior to any study procedures being performed.) 5.4 Exclusion Criteria
- Unwilling or unable to discontinue use of contact lens during the study
- Uncontrolled medical conditions that may in the judgment of the investigator confound the study assessments or limit compliance.
- Known sensitivity to corticosteroids or a known "steroid responder"
- Known hypersensitivity to the study drugs or the components or contraindications to hydrocortisone ophthalmic ointment
- Use of any systemic or topical ophthalmic antihistamine agents within 72 hours before visit 1, and that cannot be discontinued during the study
Show all 19Show fewer
- Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study.
- Regular use of systemic or topical ophthalmic non-steroidal anti-inflammatory agents (NSAID), and analgesics
- Younger than 18 years of age, Male or Female
- Unwilling to provide written informed consent
- Unlikely to complete all study visits
- Patients diagnosed with Glaucoma
- History of any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, glaucoma, blepharitis, meibomian gland disease, follicular conjunctivitis, and/or active ocular infection or inflammation.
- Use of any concurrent therapies for allergic conjunctivitis, prescription or over the counter.
- Prohibited medications include:
- topical ophthalmic or systemic corticosteroids
- topical ophthalmic/nasal antihistamines (72 hour washout period prior to baseline/screening visit and no use throughout duration of the study)
- artificial tears/ocular lubricants (72 hour washout period and no use throughout the duration of the study)
- topical ophthalmic/nasal steroids (14 day washout period prior to baseline/screening visit and no use throughout the duration of the study) (Washout period can begin after Informed Consent Document is completed by the subject.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS
The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.
Read the detailed description
Compare the safety and efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis. Demonstration of efficacy is a statistically significant improvement in itching on a 0 to 4 patient subjective assessment itch score compared to the vehicle arm and at least a 25% (or 1 full unit or more) improvement in itch scores. Efficacy for bulbar redness scores would be indicated by a statistically significant improvement in redness on a zero to 4 based on the investigators objective assessment compared to the vehicle group. Differences of at least 25% on the four point scale would be considered clinically significant when attained at the majority of time points.
- Conditions
- Allergic Conjunctivitis
- Being tested
- hydrocortisone ophthalmic ointment 0.5%, placebo
- Keywords
- allergy, allergic, conjunctivitis, corticosteroid, hydrocortisone, ophthalmic, ointment
- Medical subject headings
- Conjunctivitis, Allergic, Hypersensitivity, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisone ophthalmic ointment 0.5%Drug
Also called PF01335
- Patients will be instructed to apply Hydrocortisone Ophthalmic Ointment 0.5% or placebo in the lower cul de sac or lid margin BID
- Patients will be instructed to not use the study medications at least 2 hours prior to their appointment.
- Study medication dosing details:
- 0.05 grams hydrocortisone per gram of combination product
- each application equal to 1/20th of a gram
- total amount of active ingredient applied to each eye per application = 0.0025 grams hydrocortisone
- total amount hydrocortisone applied per eye per day = 0.005 grams hydrocortisone
- Total amount of active ingredient applied per eye throughout duration of the two week study = 0.07 grams hydrocortisone
placeboDrug
Mineral oil and white petrolatum
| Study group | Role | What they receive |
|---|---|---|
| hydrocortisone ophthalmic ointment 0.5% | Experimental | Topical ophthalmic corticosteroid ointment, is produced in a concentration of 0.5% of hydrocortisone Acetate in a vehicle composed of mineral oil and white petrolatum Receives: Drug: hydrocortisone ophthalmic ointment 0.5% |
| Placebo | Placebo comparator | mineral oil and white petrolatum Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis
Demonstration of efficacy is a statistically significant improvement in itching on a 0 to 4 patient subjective assessment itch score compared to the vehicle arm and at least a 25% (or 1 full unit or more) improvement in itch scores. Efficacy for bulbar redness scores would be indicated by a statistically significant improvement in redness on a zero to 4 based on the investigators objective assessment compared to the vehicle group. Differences of at least 25% on the four point scale would be considered clinically significant when attained at the majority of time points.
Measured: 14 days
Secondary outcomes (1)
Safety of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis
At each visit, the principal investigator or designated personnel determined to be medically qualified by the principal investigator will begin by querying for adverse events by asking each patient a general, non-directed question such as 'How have you been feeling since the last visit?' Directed questioning and examination will then be done as appropriate. All reported adverse events will be documented on the appropriate case report form.
Measured: 3 days, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completion1 Jan 2017
Why it stopped: The Sponsor has stopped responding to calls and emails
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koffler Vision Group
- Sponsor type
- University, hospital or other
- Collaborators
- Fera Pharmaceuticals, LLC
- Responsible party
- Sponsor
- Investigators
- Paul Karpecki, OD, Principal investigator, Clinical Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860664
- Sponsor's protocol ID
- F2012-05
- Status last verified
- Aug 2017
- First submitted
- 20 May 2013
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS
- ClinicalTrials.gov ID
- NCT01860664
- Acronym / sponsor ID
- F2012-05
- Conditions
- Allergic Conjunctivitis
- Keywords
- allergy, allergic, conjunctivitis, corticosteroid, hydrocortisone, ophthalmic, ointment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor has stopped responding to calls and emails
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Koffler Vision GroupUniversity, hospital or other
- Collaborators
- Fera Pharmaceuticals, LLC
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 23 May 2013 (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.
The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.
Detailed description
Compare the safety and efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis. Demonstration of efficacy is a statistically significant improvement in itching on a 0 to 4 patient subjective assessment itch score compared to the vehicle arm and at least a 25% (or 1 full unit or more) improvement in itch scores. Efficacy for bulbar redness scores would be indicated by a statistically significant improvement in redness on a zero to 4 based on the investigators objective assessment compared to the vehicle group. Differences of at least 25% on the four point scale would be considered clinically significant when attained at the majority of time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrocortisone ophthalmic ointment 0.5% | Experimental | Drug: hydrocortisone ophthalmic ointment 0.5%Topical ophthalmic corticosteroid ointment, is produced in a concentration of 0.5% of hydrocortisone Acetate in a vehicle composed of mineral oil and white petrolatum |
| Placebo | Placebo comparator | Drug: placebomineral oil and white petrolatum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of allergic conjunctivitis. b) Must be at least 18 years of age c) Must be able and willing to comply with all treatment and follow up procedures d) Best corrected visual acuity of 0.3 logMAR or better (Snellen equivalent score of 20/40 or better) in each eye at Visit 1 e) Conjunctival redness score ≥1.5 in at least one eye at Visit 1 f) Subject reported itching assessment >2.0 in at least 1 eye at Visit 1 g) Mean IOP >8 and <24 in each eye h) If female of childbearing potential, are non-lactating and non-pregnant, and must be willing to use an approved birth control method for the duration of the study, and must have a negative urine pregnancy test. (Urine pregnancy test will be conducted at Visit 1 after subject completes Informed Consent Document prior to any study procedures being performed.) 5.4 Exclusion Criteria
- Unwilling or unable to discontinue use of contact lens during the study
- Uncontrolled medical conditions that may in the judgment of the investigator confound the study assessments or limit compliance.
- Known sensitivity to corticosteroids or a known "steroid responder"
- Known hypersensitivity to the study drugs or the components or contraindications to hydrocortisone ophthalmic ointment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| hydrocortisone ophthalmic ointment 0.5%Also: PF01335* Patients will be instructed to apply Hydrocortisone Ophthalmic Ointment 0.5% or placebo in the lower cul de sac or lid margin BID * Patients will be instructed to not use the study medications at least 2 hours prior to their appointment. * Study medication dosing details: * 0.05 grams hydrocortisone per gram of combination product * each application equal to 1/20th of a gram * total amount of active ingredient applied to each eye per application = 0.0025 grams hydrocortisone * total amount hydrocortisone applied per eye per day = 0.005 grams hydrocortisone * Total amount of active ingredient applied per eye throughout duration of the two week study = 0.07 grams hydrocortisone | Drug | hydrocortisone ophthalmic ointment 0.5% |
| placeboMineral oil and white petrolatum | Drug | Placebo |
Primary outcome
Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis
Time frame: 14 days
Demonstration of efficacy is a statistically significant improvement in itching on a 0 to 4 patient subjective assessment itch score compared to the vehicle arm and at least a 25% (or 1 full unit or more) improvement in itch scores. Efficacy for bulbar redness scores would be indicated by a statistically significant improvement in redness on a zero to 4 based on the investigators objective assessment compared to the vehicle group. Differences of at least 25% on the four point scale would be considered clinically significant when attained at the majority of time points.
1 secondary outcome
Safety of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis
Time frame: 3 days, 14 days
Results and safety
The study was stopped early (reason given: The Sponsor has stopped responding to calls and emails). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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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.
Paul Karpecki, OD principal investigator
Clinical Research Director
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 hydrocortisone ophthalmic ointment 0.5% in people with Allergic Conjunctivitis, run by Koffler Vision Group 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 19 inclusion and 0 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: stopped early, as of the sponsor's last update on 18 Aug 2017. 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?
The study was stopped early (reason given: The Sponsor has stopped responding to calls and emails). Results are not available in the source record.
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?
Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis (time frame: 14 days). 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 18 Aug 2017.