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Phase IV Clinical Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye. (PRO-087)

Primary Purpose

Dry Eye

Status
Recruiting
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%
Sodium hyaluronate 0.15%
Sodium hyaluronate 0.4%
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 Dry Eye

Eligibility Criteria

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

Inclusion Criteria:

  • 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.
  • Age ≥ 18 years old
  • Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.

  • Presenting a mild to moderate dry eye disease diagnosis, defined as:

    • OSDI score ≥ 13, plus one of the following:

      • More than 5 dots of corneal staining
      • More than 9 dots of conjunctival staining
      • Tear break-up time < 10 seconds

Exclusion Criteria:

  • - Pregnancy, breastfeeding or planning to become pregnant during the time of the study
  • Having participated in clinical trials within 30 days prior to the eligibility visit.
  • Having participated previously in this study.
  • BCVA equal or worse than 20/200, in either eye.

  • Diagnosis of any of the following:

    • Allergic, viral or bacterial conjunctivitis
    • Anterior blepharitis
    • Parasite infestation of any ocular or annex structures (Demodex, for example)
    • Unresolved history of ocular trauma
    • Scarring diseases of the ocular surface
    • Corneal or conjunctival ulcers
    • Filamentary keratitis
    • Neurotrophic keratitis
    • Bullous keratopathy
    • Neoplastic diseases of the ocular surface or ocular annexes
    • Diseases presenting fibrovascular proliferations on the corneal or conjunctival surface.
    • Any retinal or posterior segment diseases that require treatment or threat the visual outcome.
    • Glaucoma
    • Any palpebral alteration that causes eyelid malposition, limiting the adequate closure or aperture of this structures, or that cause tearing.
  • Requiring management for dry eye that includes implementation of treatments described in the step 2 management recommendations of the Tear Film & Ocular Surface Society's Dry Eye Work Shop II (TFO DEWS II).
  • 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.
  • Being a contact lens user, rigid or soft. Inclusion is possible if the use of contact lenses is suspended both during the study period and at least 15 days prior inclusion takes place.
  • Previous history of any medical affliction, acute or chronic, that according to the investigator may increase either the risk to the patient for participating in this study or the risk of interference of the accurate interpretation of results.
  • Known hypersensitivity to any of the components of the products used in this study.

Sites / Locations

  • Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arm 1; Humylub Ofteno® PF

Arm 2; Hyabak®

Arm 3; Lagricel Ofteno® PF

Arm Description

Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.

Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.

Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.

Outcomes

Primary Outcome Measures

Change in Ocular Surface Disease Index (OSDI)
It is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points).

Secondary Outcome Measures

Noninvasive keratograph break-up time (NIKBUT)
This evaluation will be performed through an Oculus Keratograph 5M, and the parameter "first break-up time" will be recorded as NIKBUT. This study can take place within a time frame of 0 - 2 days between eligibility and baseline visits, and ± 2 of fist follow-up and final visits.
Change in conjunctival and corneal staining with lissamine green
The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Change in conjunctival and corneal staining with fluorescein
The evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Change in conjunctival hyperemia
Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4).
Incidence of related non expected adverse events
Presence/absence of related non expected adverse events.
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.
Change in incidence of chemosis
Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent.

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
NCT04702776
Brief Title
Phase IV Clinical Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.
Acronym
PRO-087
Official Title
Non Inferiority Phase IV Clinical Study, to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF Against Hyabak® and Lagricel Ofteno® PF When Applied on the Ocular Surface of Patients With Mild to Moderate Dry Eye.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

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
Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study
Masking
ParticipantInvestigator
Masking Description
After signing the informed consent form (ICF), every subject will receive a coded patient number and will be assigned randomly to one of the investigation products.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1; Humylub Ofteno® PF
Arm Type
Experimental
Arm Description
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Arm Title
Arm 2; Hyabak®
Arm Type
Active Comparator
Arm Description
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Arm Title
Arm 3; Lagricel Ofteno® PF
Arm Type
Active Comparator
Arm Description
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%
Other Intervention Name(s)
Humylub Ofteno® PF, PRO-087
Intervention Description
Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate 0.15%
Other Intervention Name(s)
Hyabak® PF
Intervention Description
Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate 0.4%
Other Intervention Name(s)
Lagricel Ofteno® PF, PRO-037
Intervention Description
Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Primary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI)
Description
It is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points).
Time Frame
Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary Outcome Measure Information:
Title
Noninvasive keratograph break-up time (NIKBUT)
Description
This evaluation will be performed through an Oculus Keratograph 5M, and the parameter "first break-up time" will be recorded as NIKBUT. This study can take place within a time frame of 0 - 2 days between eligibility and baseline visits, and ± 2 of fist follow-up and final visits.
Time Frame
Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Title
Change in conjunctival and corneal staining with lissamine green
Description
The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Time Frame
Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Title
Change in conjunctival and corneal staining with fluorescein
Description
The evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Time Frame
Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Title
Change in conjunctival hyperemia
Description
Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4).
Time Frame
Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Title
Incidence of related non expected adverse events
Description
Presence/absence of related non expected adverse events.
Time Frame
Days: 0 (eligibility visit), 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), 31 - 33 (± 1) (final visit), and 38 - 40 (± 1) (safety call).
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: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Title
Change in incidence of chemosis
Description
Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent.
Time Frame
Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Age ≥ 18 years old Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study. Presenting a mild to moderate dry eye disease diagnosis, defined as: OSDI score ≥ 13, plus one of the following: More than 5 dots of corneal staining More than 9 dots of conjunctival staining Tear break-up time < 10 seconds Exclusion Criteria: - Pregnancy, breastfeeding or planning to become pregnant during the time of the study Having participated in clinical trials within 30 days prior to the eligibility visit. Having participated previously in this study. BCVA equal or worse than 20/200, in either eye. Diagnosis of any of the following: Allergic, viral or bacterial conjunctivitis Anterior blepharitis Parasite infestation of any ocular or annex structures (Demodex, for example) Unresolved history of ocular trauma Scarring diseases of the ocular surface Corneal or conjunctival ulcers Filamentary keratitis Neurotrophic keratitis Bullous keratopathy Neoplastic diseases of the ocular surface or ocular annexes Diseases presenting fibrovascular proliferations on the corneal or conjunctival surface. Any retinal or posterior segment diseases that require treatment or threat the visual outcome. Glaucoma Any palpebral alteration that causes eyelid malposition, limiting the adequate closure or aperture of this structures, or that cause tearing. Requiring management for dry eye that includes implementation of treatments described in the step 2 management recommendations of the Tear Film & Ocular Surface Society's Dry Eye Work Shop II (TFO DEWS II). 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. Being a contact lens user, rigid or soft. Inclusion is possible if the use of contact lenses is suspended both during the study period and at least 15 days prior inclusion takes place. Previous history of any medical affliction, acute or chronic, that according to the investigator may increase either the risk to the patient for participating in this study or the risk of interference of the accurate interpretation of results. Known hypersensitivity to any of the components of the products used in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Sanchez-Rios, MD
Phone
+52 3330004200
Ext
1190
Email
alejandra.sanchez@sophia.com.mx
Facility Information:
Facility Name
Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44190
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magda Lorena Peña-Perez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase IV Clinical Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.

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