Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat.

NCT04702802 | Completed Results DMC

• 1 other identifier: SOPH149-0220/I
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot, controlled, parallel group, open, randomized clinical trial to evaluate the safety of the viscoelastic substance PRO-149 (sodium hyaluronate 3%) after trans-surgical administration as a device in performing phacoemulsification and intraocular lens implantation in 36 patients with age-related cataract, compared to Healon® EndoCoat (sodium hyaluronate 3%).

Conditions

Age-related Cataract; Phacoemulsification

Outcome Measures

Primary Outcomes (2)

• Change in Corneal Endothelial Cell Count

  By means of specular microscopy, endothelial cell count will take place. Density expressed in cells/mm2 will be recorded. Normal density varies according to age, but an average of 1500 - 3500 cells/mm2 (age 40 to 90) has been described.

  Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)

• Change in Intraocular Pressure (IOP)

  Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated twice to obtain an average to be recorded. Normal values are considered between 10 and 21 mmHg.

  Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])

Secondary Outcomes (5)

• Number of Participants Presenting Adverse Events

  From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit)

• Change in Central Corneal Thickness

  Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV])

• Change in Anterior Chamber Cellularity

  Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])

• Change in Anterior Chamber Flare

  Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])

• Change in Best Corrected Visual Acuity (BCVA)

  Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])

Other Outcomes (1)

• Trans-surgical Evaluation

  Days: 0 (surgery)

Study Arms (2)

Arm 1; PRO-149

EXPERIMENTAL

Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.

Device: Sodium hyaluronate 3%

Arm 2; Healon® EndoCoat

ACTIVE COMPARATOR

Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.

Device: Sodium hyaluronate 3%

Interventions

Sodium hyaluronate 3% DEVICE

During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.

Also known as: PRO-149

Arm 1; PRO-149

Eligibility Criteria

• Age: 49 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 49 years old
• Age-related cataract diagnosis which requires phacoemulsification and monofocal intraocular lens implantation
• Being capable of voluntarily grant a signed informed consent.
• Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
• Willingness to be subjected to phacoemulsification and monofocal intraocular lens implantation.
• An anterior chamber depth of ≥ 2.8 mm measured through IOL Master®.
• Pre-surgical cardiologic evaluation that validates the patient's eligibility to surgical procedure, including supporting studies: blood biometry, blood chemistry, clotting time, and electrocardiogram. This evaluation must not exceed 45 days prior to the date of signing of the informed consent.

You may not qualify if:

• Previous history of any systemic medical affliction that prevents a patient from being considered eligible for the surgical procedure under sedation and topical anesthesia.
• Previous history of Diabetes Mellitus with A1C ≥ 6.5% (48 mmol/mol) or glucose levels (after no caloric ingestion for ≥ 8 hours) of ≥ 126 mg/dL (7.0 mmol/L).
• Poorly controlled systemic arterial hypertension, defined as a value ≥ 140/90 despite the use of three antihypertensive drugs (one of them a diuretic) at maximum dose.
• Previous history of ocular diseases that may limit the BCVA, or that may reactivate or worsen due to the surgical procedure or due to the use of topical steroids (por example, retinal detachment, macular degeneration, degenerative myopia, proliferative diabetic retinopathy, diabetic macular edema, optic neuritis, uveitis or any other kind of ocular inflammation, glaucoma, intraocular hypertension, corneal dystrophies or ectasias, history of ocular herpes or zoster).
• Active ocular infection
• Pseudoexfoliation syndrome in the eye to withstand surgery, or any other such zonular compromise.
• Pharmacological mydriasis \< 6 mm.
• Any congenital anomalies in the eye to withstand surgery.
• Any alteration that prevents a reliable Goldmann tonometry in the eye to withstand surgery.
• IOP \>21mmHg in the eye to withstand surgery, or previous history of IOP \> 21 mmHg after topical steroid use.
• Corneal endothelial cell count \< 1500 cells/mm2 in the eye to withstand surgery.
• Previous history of corneal or intraocular surgery.
• Planned multiple procedures during cataract surgery (for example, trabeculectomy, keratotomies, etc)
• Previous history of ocular trauma in the eye to withstand surgery (including surgical procedures)
• Having one functional eye.

Sponsors & Collaborators

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

Study Sites (1)

SalaUno Salud, S.A.P.I. de C.V.

Mexico City, Mexico

Location

Related Publications (1)

• Palacio-Pastrana C, Munoz-Villegas P, Daniel-Dorantes F, Sanchez-Rios A, Olvera-Montano O, Martinez-Montoya YI, Quintana-Hau JD, Baiza-Duran LM. Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery. Med Devices (Auckl). 2022 Aug 24;15:293-305. doi: 10.2147/MDER.S379050. eCollection 2022.

  PMID: 36046598 DERIVED

Results Point of Contact

• Title: Alejandra Sanchez-Ríos M.D.
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

:+52 (33) 3001 4200

Study Officials

• Oscar Olvera Montaño, MD

  Regional Medical Affairs Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot, controlled, open, comparative, randomized clinical trial.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: September 7, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)