Age-related CataractPRO-149NCT04702802
Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat.
A study testing Sodium hyaluronate 3% in people with Age-related Cataract and Phacoemulsification, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 49 years and older
- Conditions the study is for
- Age-related Cataract, Phacoemulsification
- What is being tested?
- Sodium hyaluronate 3%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 7 Sep 2021to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Having participated in clinical trials within 30 days prior to signing this study's informed consent form.
- Having participated previously in this study.
- Previous history of drug addiction within the last 2 years prior to signing this study's informed consent form.
- Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.
- Having any kind of programed surgery during the period of this study.
- Being or having any immediate family members (spouse, parent/legal tutor, sibling or child) who work either in the investigation center or for the sponsor of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used as a Device During Phacoemulsification and Intraocular Lens Implantation in Patients With Age-related Cataract, Compared to Healon® EndoCoat.
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
- Being tested
- Sodium hyaluronate 3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate 3%Device
Also called PRO-149
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.
Sodium hyaluronate 3%Device
Also called Healon® EndoCoat
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sodium hyaluronate 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution.
Measured: From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit)
Change in Central Corneal Thickness
By means of specular microscopy, corneal thickness will be evaluated, reported in μm.
Measured: Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV])
Change in Anterior Chamber Cellularity
During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable, according to number of observed cells: grade 0 (none), grade ½+ (1-5 cells), grade 1+ (6-15 cells), grade 2+ (16-25 cells), grade 3+ (26-60 cells), grade 4+ (>60 cells). A higher score represents a worse outcome.
Measured: 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
During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable: grade 0 (No flare), grade 1+ (Mild), grade 2+ (Moderate; iris and lens clearly visible), grade 3+ (Marked; slightly blurry iris and lens), grade 4+ (>60 cells; fibrin). A higher score represents a worse outcome.
Measured: 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)
With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc.
Measured: 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])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start7 Sep 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, controlled, open, comparative, randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Olvera Montaño, MD, Study director, Regional Medical Affairs Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702802
- Sponsor's protocol ID
- SOPH149-0220/I
- Acronym
- PRO-149
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2021
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36046598
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used as a Device During Phacoemulsification and Intraocular Lens Implantation in Patients With Age-related Cataract, Compared to Healon® EndoCoat.
- ClinicalTrials.gov ID
- NCT04702802
- Acronym / sponsor ID
- PRO-149 / SOPH149-0220/I
- Conditions
- Age-related Cataract, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, controlled, open, comparative, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1; PRO-149 | Experimental | Device: Sodium hyaluronate 3%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. |
| Arm 2; Healon® EndoCoat | Active comparator | Device: Sodium hyaluronate 3%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. |
Who may qualify
- Ages
- 49 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium hyaluronate 3%Also: PRO-149During 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. | Device | Arm 1; PRO-149 |
| Sodium hyaluronate 3%Also: Healon® EndoCoatDuring 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. | Device | Arm 2; Healon® EndoCoat |
Primary outcome
Change in Corneal Endothelial Cell Count
Time frame: Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)
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.
Change in Intraocular Pressure (IOP)
Time frame: 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])
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.
5 secondary outcomes
Number of Participants Presenting Adverse Events
Time frame: From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit)
Change in Central Corneal Thickness
Time frame: Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV])
Change in Anterior Chamber Cellularity
Time frame: 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
Time frame: 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)
Time frame: 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])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36046598Palacio-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Olvera Montaño, MD study director
Regional Medical Affairs Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hyaluronate 3% in people with Age-related Cataract and Phacoemulsification, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Corneal Endothelial Cell Count (time frame: Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04702802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.