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

Laboratorios Sophia

Status and phase: Withdrawn; Phase 2

Conditions: Seasonal Allergic Conjunctivitis; Conjunctivitis, Allergic; Perennial Allergic Conjunctivitis; Ocular Allergy; Ocular Itching

Treatments: Drug: PRO-118 Ophthalmic Solution 0.015 %; Drug: Placebo Ophthalmic Solution; Drug: PRO-118 Ophthalmic Solution 0.020 %; Drug: PRO-118 Ophthalmic Solution 0.015%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541904

LVO1209FII

PRO-118

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 6+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 5 patient groups, including a placebo group

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

Experimental group

Treatment:

Drug: PRO-118 Ophthalmic Solution 0.015%

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

Experimental group

Treatment:

Drug: PRO-118 Ophthalmic Solution 0.015 %

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

Experimental group

Treatment:

Drug: PRO-118 Ophthalmic Solution 0.020 %

Drug: PRO-118 Ophthalmic Solution 0.020 %

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

Experimental group

Treatment:

Drug: PRO-118 Ophthalmic Solution 0.020 %

Drug: PRO-118 Ophthalmic Solution 0.020 %

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

Placebo Comparator group

Treatment:

Drug: Placebo Ophthalmic Solution