WithdrawnNCT01541904PRO-118Updated Oct 2, 2018

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

A Phase 2 interventional study of PRO-118 Ophthalmic Solution 0.015% and PRO-118 Ophthalmic Solution 0.015 % in Ocular Itching, Ocular Allergy and Seasonal Allergic Conjunctivitis, sponsored by Laboratorios Sophia S.A de C.V.. Withdrawn at 2 sites in Mexico. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Laboratorios Sophia S.A de C.V. · Phase 2, Interventional, and Treatment

Why this study was withdrawn

Reformulation

Phase: Phase 2
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 6 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Ocular Itching
Ocular Allergy
Seasonal Allergic Conjunctivitis
Perennial Allergic Conjunctivitis
Conjunctivitis, Allergic

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Keywords

Ocular Allergy.
Seasonal Allergic Conjunctivitis
Perennial Allergic Conjunctivitis
Conjunctivitis, Allergic
Ocular Antihistamines.

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

Browse Conjunctivitis studies →

Lead sponsor

Laboratorios Sophia S.A de C.V. is the lead sponsor of 44 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 0 participants (actual)

Study arms

Experimental
Arm A. PRO-118/Placebo 0.015%,0.020%
Drug: PRO-118 Ophthalmic Solution 0.015%
Experimental
Arm B. PRO-118/Placebo 0.015%,0.020%
Drug: PRO-118 Ophthalmic Solution 0.015 %
Experimental
Arm C. PRO-118/Placebo 0.015%,0.020%
Drug: PRO-118 Ophthalmic Solution 0.020 %
Experimental
Arm D. PRO-118/Placebo 0.015%,0.020%
Drug: PRO-118 Ophthalmic Solution 0.020 %
Placebo comparator
Arm E PRO-118/Placebo 0.015%,0.020%
Drug: Placebo Ophthalmic Solution

Interventions

DrugPRO-118 Ophthalmic Solution 0.015%
PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days
DrugPRO-118 Ophthalmic Solution 0.015 %
PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days
DrugPRO-118 Ophthalmic Solution 0.020 %
PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days
DrugPRO-118 Ophthalmic Solution 0.020 %
PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days
DrugPlacebo Ophthalmic Solution
Placebo Ophthalmic Solution applied qd during 21 days

What researchers measure

Primary outcomes

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).
Time frame: 21 days.

Secondary outcomes

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.
Time frame: 21 days.

Study locations

2 sites

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco 44280, Mexico
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P
Mexico City, 06800, Mexico

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01541904
Lead sponsor: Laboratorios Sophia S.A de C.V.
Responsible party: Sponsor
First posted: Mar 1, 2012
Start date: Mar 2011
Primary completion: Feb 2012
Completion: Feb 2012
Last update: Oct 2, 2018

Study contacts

María C Jiménez-Martínez, MD

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

Concepción Santacruz-Valdés, MD

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

Emma T Villaseñor-Fierro, MD

principal investigator · Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Miriam Becerra-Cotta, MD

principal investigator · Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Leopoldo M Baiza-Durán, MD

study director · Clinical Research Department. Laboratorios Sophia SA de CV

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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