Clinical trial NCT01657253: Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
Official title: A Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®

Detailed description: Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient.

A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment

Eligibility criteria: Inclusion Criteria:

* Mild to moderate dry eye patients based on the Report of International Dry Eye Workshop (DEWS)
* OSDI score between 12 and 45
* Provided informed consent

Exclusion Criteria:

* Patients with one blind eye
* Visual acuity of 20/100 or worst in any eye
* Patients with any active ocular disease that would interfere with study interpretation
* Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
* Patients with history of hypersensitivity or contraindication for any drug used in the study
* Contact lens users
* Pregnant patients, at risk of pregnancy or breastfeeding
* Patients without birth control treatment
* Patients who had participated in any clinical trial in the last 90 days
* Legal or mentally disabled patients who could not give informed consent
* Patients who do not provide informed consent

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI©) Questionnaire
timeFrame: Day 60
Secondary outcomes:
measure: Schirmer Test
timeFrame: Day 60
measure: Tear Film Break up Time
timeFrame: Day 60
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Consultorio privado
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo M Baiza-Durán, MD
role: STUDY_DIRECTOR
References:
citation: Perez-Balbuena AL, Ochoa-Tabares JC, Belalcazar-Rey S, Urzua-Salinas C, Saucedo-Rodriguez LR, Velasco-Ramos R, Suarez-Sanchez RG, Rodriguez-Carrizalez AD, Oregon-Miranda AA. Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial. BMC Ophthalmol. 2016 Sep 20;16(1):164. doi: 10.1186/s12886-016-0343-9.