Dry Eye
Conditions
Brief summary
Phase II, comparative, controlled, multicenter, parallel group, open, randomized clinical study. The main outcome variable will be the Ocular Surface Disease Index (OSDI) questionnaire. Three dosage schemes of topical ophthalmic application of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%; preservative free) are to be evaluated in patients diagnosed with mild to severe dry eye. Each group will be exposed to one of the following administration schemes: 1 drop bis in die (BID), 1 drop quater in die (QID), or 1 drop six times per day; instillation will take place in both eyes (OU).
Interventions
DRUGSodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)
Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
DRUGSodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)
Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
DRUGSodium Hyaluronate Ophthalmic 0.4% Six times per day
Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparative, controlled, multicenter, open, randomized clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old. * 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. * 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 between 13 and 32, plus one of the following: * More than 5 dots of corneal staining * More than 9 dots of conjunctival staining * Tear Break-up Time (BUT) \< 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 signing this study's informed consent form. * Having participated previously in this study. * Best Corrected Visual Acuity (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 ocular 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) | Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,). | OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms. |
| Incidence of Adverse Events (AE) | Up to Day 33 (+ 1) (safety call). | 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 and whether it was considered related or not to the investigation products. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Break-up Time (BUT) | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | After application of fluorescein stain, using a slit lamp and its cobalt blue filter, the time elapsed after instructing the patient to blink 1 or 2 times and the appearance of dry spots on the ocular surface will be counted and reported as BUT. Normally, this parameter is ≥ 10 seconds. |
| Change in Conjunctival and Corneal Staining With Lissamine Green | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | 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). |
| Change in Conjunctival and Corneal Staining With Fluorescein | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | 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). |
| Change in Conjunctival Hyperemia | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (III), and Severe (IV). |
| Incidence of Chemosis | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | 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. This evaluation will be made taking in consideration the counts of "absent" seen per counts of eyes and per visit. |
| Change in Best Corrected Visual Acuity (BCVA) | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | 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. The normal score for a VA is 20/20.This score is expressed in decimal (i.e. 1.0) format. In decimal format, a lower number is a worse outcome. |
| Change in Intraocular Pressure (IOP) | BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit). | Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP will be evaluated. Normal values are considered between 10 and 21 mmHg. |
Countries
Mexico
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 134 Participants |
| Age, Continuous | 37.95 years STANDARD_DEVIATION 14.21 |
| Brake up time of the tear film | 9.2 seconds STANDARD_DEVIATION 2.8 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Mexico | 47 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 22 / 47 | 22 / 47 | 22 / 47 |
| serious Total, serious adverse events | 1 / 47 | 0 / 47 | 0 / 47 |
Outcome results
None listed