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Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used During Phacoemulsification, Compared to Healon® EndoCoat. (PRO-149)

Primary Purpose

Age-related Cataract, Phacoemulsification

Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Sodium hyaluronate 3%
Sodium hyaluronate 3%
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cataract

Eligibility Criteria

49 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • SalaUno Salud, S.A.P.I. de C.V.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1; PRO-149

Arm 2; Healon® EndoCoat

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Incidence of 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.
Change in central corneal thickness
By means of specular microscopy, corneal thickness will be evaluated.
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 standardized scale for anterior chamber cellularity (uveitis) will be used, according to number of observed cells: 0 (none), ½+ (1-5), 1+ (6-15), 2+ (16-25), 3+ (26-60), 4+ (>60).
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 standardized scale for anterior chamber cellularity (uveitis) will be used: 0 (No flare), 1+ (Mild), 2+ (Moderate; iris and lens clearly visible), 3+ (Marked; slightly blurry iris and lens), 4+ (>60 cells; fibrin)
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.

Full Information

First Posted
January 7, 2021
Last Updated
December 22, 2021
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04702802
Brief Title
Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used During Phacoemulsification, Compared to Healon® EndoCoat.
Acronym
PRO-149
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cataract, Phacoemulsification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Pilot, controlled, open, comparative, randomized clinical trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1; PRO-149
Arm Type
Experimental
Arm Description
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 Title
Arm 2; Healon® EndoCoat
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sodium hyaluronate 3%
Other Intervention Name(s)
PRO-149
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sodium hyaluronate 3%
Other Intervention Name(s)
Healon® EndoCoat
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in corneal endothelial cell count
Description
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.
Time Frame
Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)
Title
Change in intraocular Pressure (IOP)
Description
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.
Time Frame
Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
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.
Time Frame
Days: -15 (±2) (eligibility visit), -8 (±3) (surgery scheduling visit), 0 (surgery), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
Title
Change in central corneal thickness
Description
By means of specular microscopy, corneal thickness will be evaluated.
Time Frame
Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)
Title
Change in anterior chamber cellularity
Description
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 standardized scale for anterior chamber cellularity (uveitis) will be used, according to number of observed cells: 0 (none), ½+ (1-5), 1+ (6-15), 2+ (16-25), 3+ (26-60), 4+ (>60).
Time Frame
Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
Title
Change in anterior chamber flare
Description
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 standardized scale for anterior chamber cellularity (uveitis) will be used: 0 (No flare), 1+ (Mild), 2+ (Moderate; iris and lens clearly visible), 3+ (Marked; slightly blurry iris and lens), 4+ (>60 cells; fibrin)
Time Frame
Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
Title
Change in Best Corrected Visual Acuity (BCVA)
Description
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.
Time Frame
Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
Other Pre-specified Outcome Measures:
Title
Trans-surgical evaluation
Description
During the phacoemulsification and intraocular lens implantation, the surgeon will evaluate the performance of the viscoelastic substance used during the procedure trough a questionnaire that will inquire on the following: Capability to maintain a formed anterior chamber during continuous circular capsulorhexis and intraocular lens implantation, retention during phacoemulsification, user-friendliness, ergonomics, ease of use during capsulorhexis, transparency during surgery and ease of use during extraction. Scale: 0 (very bad), 1 (bad), 2 (acceptable), 3 (good), 4 (very good).
Time Frame
Days: 0 (surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
SalaUno Salud, S.A.P.I. de C.V.
City
Ciudad de mexico
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36046598
Citation
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.
Results Reference
derived

Learn more about this trial

Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used During Phacoemulsification, Compared to Healon® EndoCoat.

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