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

NCT01541904 | Withdrawn Phase 2 DMC

• 2 other identifiers: LVO1209FIIPRO-118
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

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.

Outcome Measures

Primary Outcomes (1)

• 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).

  21 days.

Secondary Outcomes (1)

• Safety of PRO-118 Ophthalmic Solution.

  21 days.

Study Arms (5)

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

Interventions

PRO-118 Ophthalmic Solution 0.015 % DRUG

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

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

PRO-118 Ophthalmic Solution 0.020 % DRUG

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

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

Placebo Ophthalmic Solution DRUG

Placebo Ophthalmic Solution applied qd during 21 days

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

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (2)

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

Location

"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P

Mexico City, 06800, Mexico

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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"

  PRINCIPAL INVESTIGATOR

• Leopoldo M Baiza-Durán, MD

  Clinical Research Department. Laboratorios Sophia SA de CV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 1, 2012
• Study Start: March 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

ME (2)