Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome

NCT01541891 | Completed Phase 2 Results DMC

• 2 other identifiers: COXAVSSY0311FIIPRO-148
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Conditions

Dry Eye Syndrome

Keywords

PRO-148; Dry eye syndrome

Outcome Measures

Primary Outcomes (1)

• Tear Film Break-up Time (TBUT)

  TBUT was evaluated at baseline and end of the study

  During 60 days

Secondary Outcomes (1)

• Presence of Adverse Events

  60 days

Other Outcomes (1)

• Evaluation of Visual Acuity

  60 days

Study Arms (2)

PRO-148 Ophthalmic Solution

EXPERIMENTAL

Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days

Drug: PRO-148 Ophthalmic Solution

Arm B. SYSTANE® Ophthalmic Solution

ACTIVE COMPARATOR

Drug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days

Drug: Active Comparator: SYSTANE ® Ophthalmic Solution

Interventions

PRO-148 Ophthalmic Solution DRUG

PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.

Also known as: PRO-148

PRO-148 Ophthalmic Solution

Active Comparator: SYSTANE ® Ophthalmic Solution DRUG

Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.

Arm B. SYSTANE® Ophthalmic Solution

Eligibility Criteria

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

You may qualify if:

• Patients with diagnosis of mild-to-moderate drye eye syndrome.
• Male or female patients.
• Patients 18 years of age

You may not qualify if:

• Patients with one blind eye.
• Visual acuity of 20/40 in any eye
• Patients with history of active stage of any other concomitant ocular disease.
• Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present.
• Contraindications or sensitivity to any component of the study treatments.
• Ocular surgery within the past 3 months.
• Contact lens users.
• Females of childbearing potential )may not participate in the study if any of the following conditions exist:
• They are pregnant,
• They are breastfeeding,
• They have a positive urine pregnancy test at screening,
• They intend to become pregnant during the study, or
• They do not agree to use adequate birth control methods for the duration of the study.
• Discontinuation criteria:
• Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.

Sponsors & Collaborators

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

Study Sites (1)

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Baiza-Duran Leopoldo, Medical Director
• Organization: Laboratorios Sophia, SA de CV

leopoldo.baiza@sophia.com.mx

+52 (33)30014200

Study Officials

• José F Alaniz-De La O, MD

  Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

  PRINCIPAL INVESTIGATOR

• Laura R Saucedo-Rodíguez, 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 20, 2012
• First Posted: March 1, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 30, 2018
• Results First Posted: October 30, 2018

Record last verified: 2018-02

Locations

ME (1)