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Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis (PRO-118)

Primary Purpose

Ocular Itching, Ocular Allergy, Seasonal Allergic Conjunctivitis

Status

Withdrawn

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

PRO-118 Ophthalmic Solution 0.015%

PRO-118 Ophthalmic Solution 0.015 %

PRO-118 Ophthalmic Solution 0.020 %

Placebo Ophthalmic Solution

About this trial

This is an interventional treatment trial for Ocular Itching focused on measuring Ocular Allergy., Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis, Conjunctivitis, Allergic, Ocular Antihistamines.

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A. PRO-118/Placebo 0.015%,0.020%

Arm B. PRO-118/Placebo 0.015%,0.020%

Arm C. PRO-118/Placebo 0.015%,0.020%

Arm D. PRO-118/Placebo 0.015%,0.020%

Arm E PRO-118/Placebo 0.015%,0.020%

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01541904

First Posted

February 21, 2012

Last Updated

October 1, 2018

Sponsor

Laboratorios Sophia S.A de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT01541904

Brief Title

Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis

Acronym

PRO-118

Official Title

STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Reformulation

Study Start Date

March 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Sophia S.A de C.V.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A. PRO-118/Placebo 0.015%,0.020%

Arm Type

Experimental

Arm Title

Arm B. PRO-118/Placebo 0.015%,0.020%

Arm Type

Experimental

Arm Title

Arm C. PRO-118/Placebo 0.015%,0.020%

Arm Type

Experimental

Arm Title

Arm D. PRO-118/Placebo 0.015%,0.020%

Arm Type

Experimental

Arm Title

Arm E PRO-118/Placebo 0.015%,0.020%

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PRO-118 Ophthalmic Solution 0.015%

Intervention Description

PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days

Intervention Type

Drug

Intervention Name(s)

PRO-118 Ophthalmic Solution 0.015 %

Intervention Description

PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days

Intervention Type

Drug

Intervention Name(s)

PRO-118 Ophthalmic Solution 0.020 %

Intervention Description

PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days

Intervention Type

Drug

Intervention Name(s)

PRO-118 Ophthalmic Solution 0.020 %

Intervention Description

PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days

Intervention Type

Drug

Intervention Name(s)

Placebo Ophthalmic Solution

Intervention Description

Placebo Ophthalmic Solution applied qd during 21 days

Primary Outcome Measure Information:

Title

Efficacy of PRO-118 ophthalmic solution.

Description

Time Frame

21 days.

Secondary Outcome Measure Information:

Title

Safety of PRO-118 Ophthalmic Solution.

Description

Time Frame

21 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: