Allergic ConjunctivitisPhase 3NCT01657240
Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
A Phase 3 study testing PRO-118 and Olopatadine Hydrochloride in people with Allergic Conjunctivitis, run by Laboratorios Sophia S.A de C.V..
Trial summary
The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- PRO-118 and Olopatadine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 3
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provide informed consent
- Allergic conjunctivitis diagnosis
- Both genders
- Age between 6 and 60 years
- Patients with no treatment 2 years prior to study inclusion
Who cannot join
- Patients with one blind eye
- Visual acuity < 20/40 in any eye
- Patients with any active ocular disease that would interfere with study interpretation
- Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
- Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer
- Patients with history of hypersensitivity or contraindication for any drug used in the study
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- Patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators
- Pregnant patients, at risk of pregnancy or breastfeeding
- Patients without birth control treatment
- Patients who had participated in any clinical trial in the last 90 days
About this study
Official title: Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.
Read the detailed description
Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. The main aim in allergic conjunctivitis is to improve the quality of life in these patients. Antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. The aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug.
A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Patients will be randomized to receive one of the treatments for 21 days. Efficacy endpoints will be measured at baseline and at 21 days after treatment.
- Conditions
- Allergic Conjunctivitis
- Being tested
- PRO-118, Olopatadine Hydrochloride
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-118Drug
Also called PRO-118 ophthalmic solution
instill one drop in each eye once a day for 21 days
Olopatadine HydrochlorideDrug
Also called Olopatadine Hydrochloride ophthalmic solution
instill one drop in each eye once a day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| PRO-118 | Experimental | pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days Receives: Drug: PRO-118 |
| Olopatadine Hydrochloride | Active comparator | Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days Receives: Drug: Olopatadine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
conjunctival hyperemia
Change from Baseline in conjunctival hyperemia after 21 days of treatment
Measured: day 21
Secondary outcomes (1)
epiphora
Change from Baseline in epiphora after 21 days of treatment
Measured: day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startNov 2014
- Primary completionApr 2015 (estimated)
- Study completionMay 2015 (estimated)
Why it stopped: Formula Reformulation
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657240
- Sponsor's protocol ID
- SOPH118-0112/III
- Status last verified
- Oct 2018
- First submitted
- 19 Jul 2012
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01657240
- Acronym / sponsor ID
- SOPH118-0112/III
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Formula Reformulation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 6 Aug 2012 (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 evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.
Detailed description
Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. The main aim in allergic conjunctivitis is to improve the quality of life in these patients. Antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. The aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug.
A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Patients will be randomized to receive one of the treatments for 21 days. Efficacy endpoints will be measured at baseline and at 21 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO-118 | Experimental | Drug: PRO-118pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days |
| Olopatadine Hydrochloride | Active comparator | Drug: Olopatadine HydrochlorideOlopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Provide informed consent
- Allergic conjunctivitis diagnosis
- Both genders
- Age between 6 and 60 years
- Patients with no treatment 2 years prior to study inclusion
Key exclusion criteria (10 listed)
- Patients with one blind eye
- Visual acuity < 20/40 in any eye
- Patients with any active ocular disease that would interfere with study interpretation
- Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
- Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer
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 |
|---|---|---|
| PRO-118Also: PRO-118 ophthalmic solutioninstill one drop in each eye once a day for 21 days | Drug | PRO-118 |
| Olopatadine HydrochlorideAlso: Olopatadine Hydrochloride ophthalmic solutioninstill one drop in each eye once a day for 21 days | Drug | Olopatadine Hydrochloride |
Primary outcome
conjunctival hyperemia
Time frame: day 21
Change from Baseline in conjunctival hyperemia after 21 days of treatment
1 secondary outcome
epiphora
Time frame: day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRO-118 and Olopatadine Hydrochloride in people with Allergic Conjunctivitis, run by Laboratorios Sophia S.A de C.V..
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
conjunctival hyperemia (time frame: day 21). 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 2 Oct 2018.