Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease. - Clinical Trial for Dry Eye | NCT04704531

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Sodium Hyaluronate Ophthalmic 0.4% BID

Sodium Hyaluronate Ophthalmic 0.4% QID

Sodium Hyaluronate Ophthalmic 0.4% Six times per day

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  - 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.
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.

Sites / Locations

Instituto Jalisciense del Metabolismo, S.C.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.

Outcomes

Primary Outcome Measures

Change in Ocular Surface Disease Index (OSDI)

It is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points).

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.

Secondary Outcome Measures

Change in tear break-up time (BUT)

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

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

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

Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4).

Change in incidence of chemosis

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.

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.

Change in intraocular Pressure (IOP)

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.

Full Information

NCT ID

NCT04704531

First Posted

January 7, 2021

Last Updated

December 26, 2022

Sponsor

Laboratorios Sophia S.A de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT04704531

Brief Title

Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease.

Acronym

PRO-037

Official Title

Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution Applied in Three Different Dosage Schemes as Treatment for Mild to Moderate Dry Eye

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 3, 2022 (Actual)

Primary Completion Date

June 8, 2022 (Actual)

Study Completion Date

June 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Comparative, controlled, multicenter, open, randomized clinical study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.

Intervention Type

Drug

Intervention Name(s)

Sodium Hyaluronate Ophthalmic 0.4% BID

Other Intervention Name(s)

PRO-037, Lagricel® Ofteno

Intervention Description

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.

Intervention Type

Drug

Intervention Name(s)

Sodium Hyaluronate Ophthalmic 0.4% QID

Other Intervention Name(s)

PRO-037, Lagricel® Ofteno

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sodium Hyaluronate Ophthalmic 0.4% Six times per day

Other Intervention Name(s)

PRO-037, Lagricel® Ofteno

Intervention Description

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.

Primary Outcome Measure Information:

Title

Change in Ocular Surface Disease Index (OSDI)

Description

It is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points).

Time Frame

Days: 0 (baseline visit) and 31 (+1) (final visit),

Title

Incidence of adverse events

Description

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.

Time Frame

Day 33 (+ 1) (safety call).

Secondary Outcome Measure Information:

Title

Change in tear break-up time (BUT)

Description

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.

Time Frame