Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
This study is currently recruiting participants.
Verified February 2012 by Laboratorios Sophia S.A de C.V.
Sponsor:
Laboratorios Sophia S.A de C.V.
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01541904
First received: February 21, 2012
Last updated: February 29, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Itching Ocular Allergy Seasonal Allergic Conjunctivitis Perennial Allergic Conjunctivitis Conjunctivitis, Allergic |
Drug: PRO-118 Ophthalmic Solution 0.015% Drug: PRO-118 Ophthalmic Solution 0.015 % Drug: PRO-118 Ophthalmic Solution 0.020 % Drug: PRO-118 Ophthalmic Solution 0.020 % Drug: Placebo Ophthalmic Solution |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS |
Resource links provided by NLM:
Further study details as provided by Laboratorios Sophia S.A de C.V.:
Primary Outcome Measures:
- Efficacy of PRO-118 ophthalmic solution. [ Time Frame: 21 days. ] [ Designated as safety issue: No ]
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).
Secondary Outcome Measures:
- Safety of PRO-118 Ophthalmic Solution. [ Time Frame: 21 days. ] [ Designated as safety issue: Yes ]
- 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.
| Estimated Enrollment: | 35 |
| Study Start Date: | March 2011 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A. PRO-118/Placebo 0.015%,0.020% |
Drug: PRO-118 Ophthalmic Solution 0.015%
PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days
|
| Experimental: Arm B. PRO-118/Placebo 0.015%,0.020% |
Drug: PRO-118 Ophthalmic Solution 0.015 %
PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days
|
| Experimental: Arm C. PRO-118/Placebo 0.015%,0.020% |
Drug: PRO-118 Ophthalmic Solution 0.020 %
PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days
|
| Experimental: Arm D. PRO-118/Placebo 0.015%,0.020% |
Drug: PRO-118 Ophthalmic Solution 0.020 %
PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days
|
| Placebo Comparator: Arm E PRO-118/Placebo 0.015%,0.020% |
Drug: Placebo Ophthalmic Solution
Placebo Ophthalmic Solution applied qd during 21 days
|
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.
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541904
Contacts
| Contact: Leopoldo M Baiza-Durán, MD | +523330014200 ext 1051 | lbaiza@sophia.com.mx |
| Contact: Víctor M Ibarra-Durán, MD | +523330014200 ext 1193 | victor.ibarra@sophia.com.mx |
Locations
| Mexico | |
| "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P | Recruiting |
| México, D.F., D.f., Mexico, 06800 | |
| Contact: María C Jímenez-Martínez, MD +52555442700 mcjimenezm@institutodeoftalmologia.org | |
| Contact: Jorge Galicia, MD galcarj@gmail.com | |
| Principal Investigator: María C Jiménez-Martínez, MD | |
| Principal Investigator: Concepción Santacruz-Valdés, MD | |
| Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" | Recruiting |
| Guadalajara, Jalisco, Mexico, 44280 | |
| Contact: Emma T Villaseñor-Fierro, MD +523339424414 maitevf@yahoo.com.mx <maitevf@yahoo.com.mx> | |
| Contact: Miriam Becerra-Cota, MD +523339424414 | |
| Principal Investigator: Emma T Villaseñor-Fierro, MD | |
| Principal Investigator: Miriam Becerra-Cota, MD | |
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
| Principal Investigator: | María C Jiménez-Martínez, MD | "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P." |
| Principal Investigator: | Concepción Santacruz-Valdés, MD | "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P." |
| Principal Investigator: | Emma T Villaseñor-Fierro, MD | Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" |
| Principal Investigator: | Miriam Becerra-Cotta, MD | Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" |
| Study Director: | Leopoldo M Baiza-Durán, MD | Clinical Research Department. Laboratorios Sophia SA de CV |
More Information
No publications provided
| Responsible Party: | Laboratorios Sophia S.A de C.V. |
| ClinicalTrials.gov Identifier: | NCT01541904 History of Changes |
| Other Study ID Numbers: | LVO1209FII, PRO-118 |
| Study First Received: | February 21, 2012 |
| Last Updated: | February 29, 2012 |
| Health Authority: | México: Mexican Regulatory Agency. México: Mexico's Health Ministry |
Keywords provided by Laboratorios Sophia S.A de C.V.:
|
Ocular Allergy. Seasonal Allergic Conjunctivitis Perennial Allergic Conjunctivitis Conjunctivitis, Allergic Ocular Antihistamines. |
Additional relevant MeSH terms:
|
Hypersensitivity Conjunctivitis Conjunctivitis, Allergic Immune System Diseases |
Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 19, 2013