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.

Dry Eye Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702776
• Other study ID #: SOPH087-0120/IV
• Status: Completed
• Phase: Phase 4
• Start date: December 9, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: January 2024
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%
Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
• Sodium hyaluronate 0.15%
Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
• Sodium hyaluronate 0.4%
Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.

Locations

Country	Name	City	State
Mexico	Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary	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.	Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary	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).	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary	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).	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary	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).	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary	Incidence of related non expected adverse events	Presence/absence 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).
Secondary	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.	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary	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.	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).