Trial | NCT01541904  Report issue

Title

Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    propantheline bromide ...

  • Study Participants

    0
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.
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 Started
Mar 31
2011
Primary Completion
Feb 29
2012
Study Completion
Feb 29
2012
Last Update
Oct 02
2018

Drug PRO-118 Ophthalmic Solution 0.015%

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

Drug PRO-118 Ophthalmic Solution 0.015 %

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

Drug PRO-118 Ophthalmic Solution 0.020 %

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

Drug PRO-118 Ophthalmic Solution 0.020 %

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

Drug Placebo Ophthalmic Solution

Placebo Ophthalmic Solution applied qd during 21 days

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

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

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

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

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

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.
No Results Posted