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

NCT04702776 | Completed Phase 4 Results DMC

• 1 other identifier: SOPH087-0120/IV
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Change in Ocular Surface Disease Index (OSDI)

  OSDI 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). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.

  Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Secondary Outcomes (7)

• Noninvasive Keratograph Break-up Time (NIKBUT)

  Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

• Change of Conjunctival and Corneal Staining With Lissamine Green

  Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

• Change of Conjunctival and Corneal Staining With Fluorescein

  Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

• Change in Conjunctival Hyperemia

  Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

• Incidence of Related Non Expected Adverse Events

  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).

Study Arms (3)

Arm 1; Humylub Ofteno® PF

EXPERIMENTAL

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

Drug: Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%

Arm 2; Hyabak®

ACTIVE COMPARATOR

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

Drug: Sodium hyaluronate 0.15%

Arm 3; Lagricel Ofteno® PF

ACTIVE COMPARATOR

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

Drug: Sodium hyaluronate 0.4%

Interventions

Sodium hyaluronate 0.1%/chondroitin sulfate 0.18% DRUG

Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.

Also known as: Humylub Ofteno® PF, PRO-087

Arm 1; Humylub Ofteno® PF

Sodium hyaluronate 0.15% DRUG

Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.

Also known as: Hyabak® PF

Arm 2; Hyabak®

Sodium hyaluronate 0.4% DRUG

Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.

Also known as: Lagricel Ofteno® PF, PRO-037

Arm 3; Lagricel Ofteno® PF

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

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

Study Sites (1)

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

Guadalajara, Jalisco, 44190, Mexico

Location

Related Publications (1)

• Munoz-Villegas P, Garcia-Sanchez G, Jauregui-Franco RO, Quirarte-Justo S, Sanchez-Rios A, Olvera-Montano O. Influence of Environmental Factors with Clinical Signs and Symptoms in the Management of Dry Eye Disease. Clin Ophthalmol. 2024 Aug 30;18:2439-2451. doi: 10.2147/OPTH.S480223. eCollection 2024.

  PMID: 39233999 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Alejandra Sanchez Ríos
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

+ 52 33 3001 4200

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: December 9, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: February 20, 2026
• Results First Posted: January 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)