Ocular ItchingPhase 2PRO-118NCT01541904
Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
A Phase 2 study testing PRO-118 Ophthalmic Solution 0.015%, PRO-118 Ophthalmic Solution 0.015 % and PRO-118 Ophthalmic Solution 0.020 % in people with Ocular Itching and Ocular Allergy, run by Laboratorios Sophia S.A de C.V. at 2 sites in Mexico.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Ocular Itching, Ocular Allergy, Seasonal Allergic Conjunctivitis
- What is being tested?
- PRO-118 Ophthalmic Solution 0.015%, PRO-118 Ophthalmic Solution 0.015 % and PRO-118 Ophthalmic Solution 0.020 %
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesMexico
- Study dates
- Mar 2011to Feb 2012
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diagnosis of seasonal or perennial allergic conjunctivitis.
- Age ≥ 6 years old at screening visit.
- Male or female patients.
- Applicable in patients ≥ 18 years old.
- Patient has signed the Informed Consent Form (ICF) prior to any screening procedures.
- Applicable in patients with age ≤ 18 years old.
- Patients Patients'parents or legal guardians signed an Informed Consent Form (ICF).
- The patients also provided written assent.
Who cannot join
- Presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (Atopic keratoconjunctivitis, giant papillary conjunctivitis).
- Any other ophthalmic medication within seven days prior to randomization.
- Patient with one blind eye.
- Visual acuity of 20/40 in any eye.
- Patients with history of active stage of any other concomitant ocular disease.
- Contraindications or sensitivity to any component of the study treatments.
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- Contact lens users.
- Ocular surgery within the past 3 months.
- Women who were not using an effective means of contraception or who were pregnant or nursing.
- Participation in any studies of investigational drugs within 90 days previous to the inclusion.
- Discontinuation criteria:
- Patients could be discontinued before the completion of the study because of use of prohibited medications, adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P
Mexico City, 06800
About this study
Official title: STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS
The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
Read the detailed description
A phase II, double-masked, randomized, placebo-controlled, parallel-group and multicenter clinical trial, to evaluate and compared the clinical efficacy and safety of four doses of PRO-118 ophthalmic solution ( PRO-118 0.015% qd, PRO-118 0.015% twice daily , PRO-118 0.020% qd, PRO-118 0.020% twice daily) for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
- Conditions
- Ocular Itching, Ocular Allergy, Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis, Conjunctivitis, Allergic
- Being tested
- PRO-118 Ophthalmic Solution 0.015%, PRO-118 Ophthalmic Solution 0.015 %, PRO-118 Ophthalmic Solution 0.020 %, Placebo Ophthalmic Solution
- Keywords
- Ocular Allergy., Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis, Conjunctivitis, Allergic, Ocular Antihistamines.
- 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-118 Ophthalmic Solution 0.015%Drug
PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days
PRO-118 Ophthalmic Solution 0.015 %Drug
PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days
PRO-118 Ophthalmic Solution 0.020 %Drug
PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days
PRO-118 Ophthalmic Solution 0.020 %Drug
PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days
Placebo Ophthalmic SolutionDrug
Placebo Ophthalmic Solution applied qd during 21 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A. PRO-118/Placebo 0.015%,0.020% | Experimental | Not described Receives: Drug: PRO-118 Ophthalmic Solution 0.015% |
| Arm B. PRO-118/Placebo 0.015%,0.020% | Experimental | Not described Receives: Drug: PRO-118 Ophthalmic Solution 0.015 % |
| Arm C. PRO-118/Placebo 0.015%,0.020% | Experimental | Not described Receives: Drug: PRO-118 Ophthalmic Solution 0.020 % |
| Arm D. PRO-118/Placebo 0.015%,0.020% | Experimental | Not described Receives: Drug: PRO-118 Ophthalmic Solution 0.020 % |
| Arm E PRO-118/Placebo 0.015%,0.020% | Placebo comparator | Not described Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PRO-118 ophthalmic solution.
Primary efficacy measure: Evaluation of ocular itching.
Secondary efficacy measures: Evaluation of symptoms(redness eye,ocular irritation, foreign body sensation, photophobia and lacrimation) and signs(conjunctival hyperaemia,chemosis, mucous discharge ocular and presence of follicles/papillae).
Measured: 21 days.
Secondary outcomes (1)
Safety of PRO-118 Ophthalmic Solution.
- Evaluation of ocular symptoms and signs, visual acuity (VA), biomicroscopy, intraocular pressure (IOP), funduscopy and cup disc-ratio.
- Frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.
Measured: 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Reformulation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular ItchingStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María C Jiménez-Martínez, MD, Principal investigator, "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."Concepción Santacruz-Valdés, MD, Principal investigator, "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."Emma T Villaseñor-Fierro, MD, Principal investigator, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Miriam Becerra-Cotta, MD, Principal investigator, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Leopoldo M Baiza-Durán, MD, Study director, Clinical Research Department. Laboratorios Sophia SA de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541904
- Sponsor's protocol ID
- LVO1209FII
- Other IDs
- PRO-118
- Acronym
- PRO-118
- Status last verified
- Oct 2018
- First submitted
- 21 Feb 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
- STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS
- ClinicalTrials.gov ID
- NCT01541904
- Acronym / sponsor ID
- PRO-118 / LVO1209FII
- Conditions
- Ocular Itching, Ocular Allergy, Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis, Conjunctivitis, Allergic
- Keywords
- Ocular Allergy., Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis, Conjunctivitis, Allergic, Ocular Antihistamines.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Reformulation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Mar 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 efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
Detailed description
A phase II, double-masked, randomized, placebo-controlled, parallel-group and multicenter clinical trial, to evaluate and compared the clinical efficacy and safety of four doses of PRO-118 ophthalmic solution ( PRO-118 0.015% qd, PRO-118 0.015% twice daily , PRO-118 0.020% qd, PRO-118 0.020% twice daily) for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A. PRO-118/Placebo 0.015%,0.020% | Experimental | Drug: PRO-118 Ophthalmic Solution 0.015% |
| Arm B. PRO-118/Placebo 0.015%,0.020% | Experimental | Drug: PRO-118 Ophthalmic Solution 0.015 % |
| Arm C. PRO-118/Placebo 0.015%,0.020% | Experimental | Drug: PRO-118 Ophthalmic Solution 0.020 % |
| Arm D. PRO-118/Placebo 0.015%,0.020% | Experimental | Drug: PRO-118 Ophthalmic Solution 0.020 % |
| Arm E PRO-118/Placebo 0.015%,0.020% | Placebo comparator | Drug: Placebo Ophthalmic Solution |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with diagnosis of seasonal or perennial allergic conjunctivitis.
- Age ≥ 6 years old at screening visit.
- Male or female patients.
- Applicable in patients ≥ 18 years old.
- Patient has signed the Informed Consent Form (ICF) prior to any screening procedures.
Key exclusion criteria (12 listed)
- Presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (Atopic keratoconjunctivitis, giant papillary conjunctivitis).
- Any other ophthalmic medication within seven days prior to randomization.
- Patient with one blind eye.
- Visual acuity of 20/40 in any eye.
- Patients with history of active stage of any other concomitant ocular disease.
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-118 Ophthalmic Solution 0.015%PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days | Drug | Arm A. PRO-118/Placebo 0.015%,0.020% |
| PRO-118 Ophthalmic Solution 0.015 %PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days | Drug | Arm B. PRO-118/Placebo 0.015%,0.020% |
| PRO-118 Ophthalmic Solution 0.020 %PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days | Drug | Arm C. PRO-118/Placebo 0.015%,0.020% |
| PRO-118 Ophthalmic Solution 0.020 %PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days | Drug | Arm D. PRO-118/Placebo 0.015%,0.020% |
| Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution applied qd during 21 days | Drug | Arm E PRO-118/Placebo 0.015%,0.020% |
Primary outcome
Efficacy of PRO-118 ophthalmic solution.
Time frame: 21 days.
Primary efficacy measure: Evaluation of ocular itching. Secondary efficacy measures: Evaluation of symptoms(redness eye,ocular irritation, foreign body sensation, photophobia and lacrimation) and signs(conjunctival hyperaemia,chemosis, mucous discharge ocular and presence of follicles/papillae).
1 secondary outcome
Safety of PRO-118 Ophthalmic Solution.
Time frame: 21 days.
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.
María C Jiménez-Martínez, MD principal investigator
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."
Concepción Santacruz-Valdés, MD principal investigator
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."
Emma T Villaseñor-Fierro, MD principal investigator
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRO-118 Ophthalmic Solution 0.015%, PRO-118 Ophthalmic Solution 0.015 % and PRO-118 Ophthalmic Solution 0.020 % in people with Ocular Itching and Ocular Allergy, run by Laboratorios Sophia S.A de C.V. at 2 sites in Mexico.
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 8 inclusion and 12 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.
Where is the study taking place?
The record lists 2 sites in Mexico. 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 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?
Efficacy of PRO-118 ophthalmic solution. (time frame: 21 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 2 Oct 2018.