Phase IV Clinical Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo for Corneal Re-epithelialization After Photorefractive Keratectomy (PRK)
Overview
- Phase
- Phase 4
- Intervention
- Sodium Hyaluronate Ophthalmic 0.4%
- Conditions
- Photorefractive Keratectomy
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Changes in corneal re-epithelialization (time)
- Status
- Completed
- Last Updated
- 25 days ago
Overview
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.
Investigators
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
- •Anterior blepharitis
- •Parasite infestation of ocular structures (Demodex, for example)
Arms & Interventions
Group 1; Lagricel® Ofteno PF
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Intervention: Sodium Hyaluronate Ophthalmic 0.4%
Group 2; Thealoz® Duo
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Intervention: Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%
Outcomes
Primary Outcomes
Changes in corneal re-epithelialization (time)
Time Frame: Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)
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.
Incidence of adverse events
Time Frame: Day: 15 (±1) (final visit)
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.
Change in Best Corrected Visual Acuity (BCVA)
Time Frame: 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)
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.
Changes in Corneal Re-epithelialization (Time)
Time Frame: Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)
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.
Best Corrected Visual Acuity (BCVA)
Time Frame: Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)
(VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.
Secondary Outcomes
- 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))
- Changes in Ocular Comfort Index(Days: 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV))
- Pain Perception(Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV))
- Frequency of Pain Perception(Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV))
- Unexpected Adverse Events (AEs) Related to the Investigational Product(Day: 17 (± 1) (safety call))