Phase IV Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (PRK)

NCT04704518 | Completed Phase 4 DMC

• 1 other identifier: SOPH037-0120/IV
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Phase IV comparative, controlled, parallel group, open, randomized multicenter study to evaluate the efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo. Primary outcome measure is the time of corneal re-epithelialization after PRK surgery. Intervention includes administration of one of the experimental products quater per die (QID) for 14 days.

Conditions

Photorefractive Keratectomy; Corneal De-epithelialization

Outcome Measures

Primary Outcomes (3)

• Changes in corneal re-epithelialization (time)

  Corneal re-epithelialization will be evaluated through direct observation and photographic recording after application of fluorescein stain. After instillation of a drop of topical anesthetic (tetracaine 0.5%) a fluorescein strip will be applied on the inferior cul de sac while the patient looks upward. Using a slit lamp with magnification of 6x and 16x photographs (at least 6 images for each magnification) will be obtained.

  Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)

• 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.

  Day: 15 (±1) (final visit)

• 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: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit) and 15 (±1) (final visit)

Secondary Outcomes (2)

• Changes in Ocular Comfort Index

  Days: 7 (±1) (third follow-up visit) and 15 (±1) (final visit)

• Pain perception

  Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit) and 15 (±1) (final visit)

Study Arms (2)

Group 1; Lagricel® Ofteno PF

EXPERIMENTAL

Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.

Drug: Sodium Hyaluronate Ophthalmic 0.4%

Group 2; Thealoz® Duo

ACTIVE COMPARATOR

Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.

Drug: Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%

Interventions

Sodium Hyaluronate Ophthalmic 0.4% DRUG

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

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

Group 1; Lagricel® Ofteno PF

Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15% DRUG

Topical ophthalmic administration of one drop of Thealoz® Duo QID.

Also known as: Thealoz® Duo

Group 2; Thealoz® Duo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Age ≥ 18 and ≤ 45 years old
• Being on PRK postoperative day 1 (right eye will be evaluated for efficacy)
• Presenting a PRK surgical corneal ablation surface of 5.5 to 6.0 mm
• PRK corneal output ≤ 60 µm
• Preoperative refraction of -1.0 to -4.5 D of myopia or myopic astigmatism (in this case, the sum of both values with a spherical equivalent no greater than -4.5 D)
• 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.
• Being willing and able to modify the required lifestyle activities.
• 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.

You may not qualify if:

• Use of mitomycin during PRK
• Being subjected to PRK retreatment of previous history of any other kind of refractive surgery.
• 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.
• Diagnosis of any of the following:
• Allergic, viral or bacterial conjunctivitis
• Dry eye
• Anterior blepharitis
• Parasite infestation of ocular structures (Demodex, for example)
• Previous history of ocular herpes
• Previous history of ocular inflammation (such as uveitis)
• Corneal or conjunctival ulcers
• Glaucoma
• Previous history of drug addiction within the last 2 years previous to signing this study's informed consent form.

Sponsors & Collaborators

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

Study Sites (1)

Aris Vision Institute de Guadalajara, S. C.

Guadalajara, Jalisco, Mexico

Location

MeSH Terms

Interventions

Trehalose

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, controlled, parallel group, open, randomized multicenter study

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: September 3, 2022
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: April 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)