Allergic ConjunctivitisPhase 4NCT04776096
Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment
A Phase 4 study testing Bepotastine Besilate 1.5% PF and Olopatadine Hydrochloride 0.2% BAK in people with Allergic Conjunctivitis, run by Laboratorios Poen at 4 sites in Argentina.
Trial summary
The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with 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?
- Bepotastine Besilate 1.5% PF and Olopatadine Hydrochloride 0.2% BAK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 4 sitesArgentina
- Study dates
- 10 Mar 2021to 18 Aug 2022
- Phase
- Phase 4
- 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
- Patients older than 18 years old.
- Clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale.
- Patients with history of allergic conjunctivitis.
- Patients who accept no to wear contact lens during the duration of the trial.
- Patients who accept no to use any other medication by any delivery route.
- Patients with intraocular pressure controlled (less than 18 mmhg)
Who cannot join
- Patients who have undergone refractive surgery within the 6 months prior to the start of the study
- Patient with ocular or systemic active diseases
- Patients who are participating in another trial
- Patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or NSAIDs) and/or antihistamines by mouth or intravenous.
- Patients hypersensitive to any component of the products: Bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, Olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone K29 / 32.
- Women who are breastfeeding and pregnant.
Trial locations and contacts
4 sites in 1 country.
Argentina4 sites
Hospital de Alta Complejidad El Cruce - Nestor Kirchner
CABA, B1888
Hospital Santa Lucía
CABA, C1232AAC
Instituto Oftalmológico Pedro Lagleyze
CABA, C1416 DJI
Hospital Churruca - Visca
CABA, C1437
About this study
Official title: PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS
The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis.
The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Bepotastine Besilate 1.5% PF, Olopatadine Hydrochloride 0.2% BAK
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bepotastine Besilate 1.5% PFDrug
Also called TRALER LC
Bepotastine besilate 1,5% Preservative free ophthalmic solution
Olopatadine Hydrochloride 0.2% BAKDrug
Olopatadine hydrochloride 0.2% with BAK as preservative
| Study group | Role | What they receive |
|---|---|---|
| Bepotastine besilate 1,5% preservative free | Experimental | Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning. Receives: Drug: Bepotastine Besilate 1.5% PF |
| Olopatadine hydrochloride 0,2% with BAK | Active comparator | Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning. Receives: Drug: Olopatadine Hydrochloride 0.2% BAK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching
Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Secondary outcomes (14)
Eye burning
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Eye lacrimation
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Foreign body sensation
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Rhinorrhea
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Nasal congestion
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Nasal pruritus
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Eyelid swelling
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Visual Acuity
Improve from baseline.
Measured: Baseline and Day 60
Meniscus height
Differences between treatments.
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Conjunctival hyperemia
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Chemosis
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Eye discharge
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Measured: Baseline, Day 15, Day 30, Day 45, Day 60
Conjuctival impression cytology
Differences between treatments. Nelson classification.
Measured: Baseline, Day 30, Day 60
Adverse reactions
Measured: Baseline, Day 15, Day 30, Day 45, Day 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start10 Mar 2021
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Poen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776096
- Sponsor's protocol ID
- ANTILERG001-19
- Status last verified
- Dec 2022
- First submitted
- 25 Feb 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS
- ClinicalTrials.gov ID
- NCT04776096
- Acronym / sponsor ID
- ANTILERG001-19
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Laboratorios PoenIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- 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 present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis.
The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
| Arm | Type | Receives |
|---|---|---|
| Bepotastine besilate 1,5% preservative free | Experimental | Drug: Bepotastine Besilate 1.5% PFBepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning. |
| Olopatadine hydrochloride 0,2% with BAK | Active comparator | Drug: Olopatadine Hydrochloride 0.2% BAKOlopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 18 years old.
- Clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale.
- Patients with history of allergic conjunctivitis.
- Patients who accept no to wear contact lens during the duration of the trial.
- Patients who accept no to use any other medication by any delivery route.
Key exclusion criteria (6 listed)
- Patients who have undergone refractive surgery within the 6 months prior to the start of the study
- Patient with ocular or systemic active diseases
- Patients who are participating in another trial
- Patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or NSAIDs) and/or antihistamines by mouth or intravenous.
- Patients hypersensitive to any component of the products: Bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, Olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone K29 / 32.
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 |
|---|---|---|
| Bepotastine Besilate 1.5% PFAlso: TRALER LCBepotastine besilate 1,5% Preservative free ophthalmic solution | Drug | Bepotastine besilate 1,5% preservative free |
| Olopatadine Hydrochloride 0.2% BAKOlopatadine hydrochloride 0.2% with BAK as preservative | Drug | Olopatadine hydrochloride 0,2% with BAK |
Primary outcome
Ocular itching
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.
14 secondary outcomes
Eye burning
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Eye lacrimation
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Foreign body sensation
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Rhinorrhea
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Nasal congestion
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Nasal pruritus
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Eyelid swelling
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Visual Acuity
Time frame: Baseline and Day 60
Meniscus height
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Conjunctival hyperemia
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Chemosis
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Eye discharge
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Conjuctival impression cytology
Time frame: Baseline, Day 30, Day 60
Adverse reactions
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bepotastine Besilate 1.5% PF and Olopatadine Hydrochloride 0.2% BAK in people with Allergic Conjunctivitis, run by Laboratorios Poen at 4 sites in Argentina.
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 6 inclusion and 6 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 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Baseline, Day 15, Day 30, Day 45, Day 60). 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 15 Dec 2022.