Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease.

NCT04704531 | Completed Phase 2 Results DMC

• 1 other identifier: SOPH037-1219/II
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II, comparative, controlled, multicenter, parallel group, open, randomized clinical study. The main outcome variable will be the Ocular Surface Disease Index (OSDI) questionnaire. Three dosage schemes of topical ophthalmic application of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%; preservative free) are to be evaluated in patients diagnosed with mild to severe dry eye. Each group will be exposed to one of the following administration schemes: 1 drop bis in die (BID), 1 drop quater in die (QID), or 1 drop six times per day; instillation will take place in both eyes (OU).

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Change in Ocular Surface Disease Index (OSDI)

  OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.

  Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).

• Incidence of Adverse Events (AE)

  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 and whether it was considered related or not to the investigation products.

  Up to Day 33 (+ 1) (safety call).

Secondary Outcomes (7)

• Change in Tear Break-up Time (BUT)

  Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

• Change in Conjunctival and Corneal Staining With Lissamine Green

  Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

• Change in Conjunctival and Corneal Staining With Fluorescein

  Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

• Change in Conjunctival Hyperemia

  Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

• Incidence of Chemosis

  Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

Study Arms (3)

Group 1

EXPERIMENTAL

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop twice a day (BID) in both eyes (OU) during 30 days.

Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)

Group 2

EXPERIMENTAL

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop four times a day (QID) in both eyes (OU) during 30 days.

Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)

Group 3

EXPERIMENTAL

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.

Drug: Sodium Hyaluronate Ophthalmic 0.4% Six times per day

Interventions

Sodium Hyaluronate Ophthalmic 0.4% Six times per day DRUG

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.

Also known as: PRO-037, Lagricel® Ofteno

Group 3

Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID) DRUG

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.

Also known as: PRO-037, Lagricel® Ofteno

Group 1

Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID) DRUG

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.

Also known as: PRO-037, Lagricel® Ofteno

Group 2

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old.
• 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.
• 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 between 13 and 32, plus one of the following:
• More than 5 dots of corneal staining
• More than 9 dots of conjunctival staining
• Tear Break-up Time (BUT) \< 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 signing this study's informed consent form.
• Having participated previously in this study.
• Best Corrected Visual Acuity (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 ocular 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)

Instituto Jalisciense del Metabolismo, S.C.

Guadalajara, Jalisco, 44670, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Alejandra Sanchez-Ríos M.D.
• 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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, controlled, multicenter, open, randomized clinical study.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: January 3, 2022
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)