Phase 4
Completed N=96
Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy
Photorefractive Keratectomy · Corneal De-epithelialization
Source: ClinicalTrials.gov NCT04704518 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Changes in Corneal Re-epithelialization (Time) — 5.39; 5.34 days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Corneal Re-epithelialization (Time) |
5.39; 5.34 | — |
| PRIMARY Best Corrected Visual Acuity (BCVA) |
0.58; 0.61; 0.53; 0.55; 0.62; 0.65 | — |
| SECONDARY Changes in Ocular Comfort Index |
25.20; 25.25; 20.32; 19.51 | — |
| SECONDARY Pain Perception |
3; 3; 4; 7; 8; 11 | — |
| SECONDARY Frequency of Pain Perception |
3; 3; 12; 9; 9; 10 | — |
| SECONDARY Unexpected Adverse Events (AEs) Related to the Investigational Product |
17; 12; 2; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04704518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.