Phase IV Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (PRK) (PRO-037)

Laboratorios Sophia

Status and phase: Completed; Phase 4

Conditions: Photorefractive Keratectomy; Corneal De-epithelialization

Treatments: Drug: Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%; Drug: Sodium Hyaluronate Ophthalmic 0.4%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04704518

SOPH037-0120/IV

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • 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.

Exclusion criteria

• Having suffered any complications during and after PRK surgical procedure previous to inclusion in the study.

• 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.

• Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.

• Previous history of any medical affliction, acute or chronic (such as Diabetes Mellitus type I/II, autoimmune diseases or HIV), 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.

• Use of medications (such as retinoic acid) that according to the investigator's criteria 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Group 1; Lagricel® Ofteno PF

Experimental group

Description:

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

Treatment:

Drug: Sodium Hyaluronate Ophthalmic 0.4%

Group 2; Thealoz® Duo

Active Comparator group

Description:

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

Treatment:

Drug: Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%