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Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Softacort

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
Normal ophthalmic findings except dry eye disease
Ametropy ≤ 6 diopters
Chronic dry eye defined as longer than six months since diagnosis
OSDI ≥ 22
Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
Current use of topical lubricants since at least 3 months

Exclusion criteria:

Best far corrected visual acuity < 1/10
Severe Dry Eye associated with:
Eyelid malposition
Sjogren Syndrome
Steven Johnson Syndrome
Corneal dystrophy
Ocular neoplasia
Filamentous keratitis
Corneal neovascularisation
Orbital radiotherapy
History of any of the following within last 3 months:
Systemic treatment of dry eye
Systemic treatment of MGD
Isotretinoide,
Cyclosporine,
Tacrolimus, Siromilus, Pimecrolimus
Punctual plugs
Anti-glaucoma treatment
History of any of the following within previous six months:
ocular trauma
ocular infection, ocular allergy
History of any of the following within last 12 months:
inflammatory corneal ulcer
Herpetic eye infection or uveitis
Ocular surgery
History of IOP increase caused by systemic or topical treatment with corticosteroids
IOP > 22mmHg
Glaucoma in the medical history
Known hypersensitivity to any of the components of the IMP under investigation or other study medication
Allergic rhinitis; active or susceptible to reactivation during the study
Pregnant or breast-feeding woman.
Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intrauterine device, contraceptive implant or condoms)
Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
Participation in another clinical study or clinical investigation at the same time as the present investigation
Participation to the present clinical investigation during the exclusion period of another clinical study
Patient already included once in this clinical investigation
Patient under guardianship

Sites / Locations

Department of Clinical Pharmacology, Medical University Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

intense

standard

Arm Description

Patients have been randomized to receive Softacort eye drops for 12 days 4 times daily followed by 2 days twice daily treatment resulting in a total time of 14 days

Patients have been randomized to receive Softacort eye drops for 8 days 3 times daily followed by 3 days twice daily treatment resulting in a treatment time of 11 days total

Outcomes

Primary Outcome Measures

Conjunctival hyperemia

Conjunctival hyperemia will be graded according to the Efron Scale: 0=none, 1=trace, 2 = mild, 3 = moderate, 4 = severe

Secondary Outcome Measures

Full Information

NCT ID

NCT03907865

First Posted

April 5, 2019

Last Updated

August 9, 2019

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT03907865

Brief Title

Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

Official Title

Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

March 27, 2018 (Actual)

Primary Completion Date

November 28, 2018 (Actual)

Study Completion Date

January 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests the use of anti-inflammatory drugs such as corticosteroids, cyclosporine or others when topical lubricants alone are not sufficient. Recently, Softacort® eye drops containing 0.335% hydrocortisone have gained marketing authorization for the treatment of ocular surface inflammation. This formulation offers several advantages that make them potentially interesting for the treatment of DED. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. Further, hydrocortisone has the advantage that in comparison to other glucocorticoid derivatives, it features poor solubility. This means that corneal penetration is low, which is a desired effect in the treatment of ocular surface inflammation. Because of the poor penetration through thecornea, elevation of intraocular pressure and cataract formation, which are common side effect of corticosteroid treatment, have not been observed with Softacort® to date, also favoring the use of this agent in DED. The aim of the present study is to investigate whether treatment with Softacort® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED in patients who are already taking topical lubricants for at least three months.

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 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intense

Arm Type

Experimental

Arm Description

Patients have been randomized to receive Softacort eye drops for 12 days 4 times daily followed by 2 days twice daily treatment resulting in a total time of 14 days

Arm Title

standard

Arm Type

Experimental

Arm Description

Patients have been randomized to receive Softacort eye drops for 8 days 3 times daily followed by 3 days twice daily treatment resulting in a treatment time of 11 days total

Intervention Type

Drug

Intervention Name(s)

Softacort

Intervention Description

Group 1: 4 times daily for the first 12 days of the treatment period and then 2 times daily for 2 additional days Group 2: 3 times daily for the first 8 days of the treatment period and then 2 times daily for 3 additional days

Primary Outcome Measure Information:

Title

Conjunctival hyperemia

Description

Conjunctival hyperemia will be graded according to the Efron Scale: 0=none, 1=trace, 2 = mild, 3 = moderate, 4 = severe

Time Frame

5 minutes

Other Pre-specified Outcome Measures:

Title

Corneal fluorescein staining according to the Oxford Scale

Description

Minims-Fluorescein Sodium 2.0% eye drops will be used to detect corneal epithelial defects. As grading scale for corneal damage, the NEI/Industry Workshop guidelines will be used 1. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, whereas 0 means no staining and 3 means maximum staining, with a maximal score of 15. Corneal staining will also be graded according to the Oxford Scale (Annex II).

Time Frame

5 minutes

Title

Tear film thickness

Description

Tear film thickness as measured with ultra-high resolution optical coherence tomography (OCT)

Time Frame

30 minutes

Title

Tear osmolarity

Description

Tear film osmolarity will be measured non-invasive with a commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA). The TearLab® technology uses an approach that concentrates laboratory functions on a single chip that requires less than 50 nL of tear fluid in order to measure tear osmolarity. The system uses a handheld pen on which the ophthalmologist places the noninvasive laboratory chip test card. Then the tear sample is collected by pressing the tip of the pen towards the conjunctiva adjacent to the lower lid margin. The collection of the tear sample takes usually less than 30 seconds and is painless for the subject.

Time Frame

5 minutes

Title

HLA-DR expression

Description

2 samples will be taken from the upper conjunctiva of the study eye using EYEPRIM™ (Opia Technologies S.A.S., Paris, France). The subject will be instructed to look down. The device will be positioned upon the conjunctiva. Then, the push-button will be pressed until the stop position is reached and then be held in this position for 2-3 seconds. Afterwards, the pressure will be released and the device will be removed from the eye. The sampling membrane will be ejected in a storage container by pressing the push-button once again. The samples will be stored according to the manufacturer's instructions and will be sent under observer blinded conditions to an independent laboratory (Iris Pharma, La Gaude, France) for analysis and assessment of HLA-DR levels.

Time Frame

20 minutes

Title

Description

Symptoms of dry eye will be assessed using the Ocular Surface Disease Index© (OSDI©) which was developed by the Outcomes Research Group at Allergan Inc (Irvine, Calif)27. The questionnaire that underlies the OSDI© is specifically designed for patients with dry eye syndrome and asks patients about the frequency of specific symptoms and their impact on vision-related functioning. A sample of the OSDI© in German is given in Annex III.

Time Frame

5 minutes

Title

Intraocular pressure

Description

Intraocular pressure will be measured with a slit-lamp mounted Goldmann Applanation Tonometer. Before each measurement one drop of oxybuprocainhydrochloride combined with sodium fluorescein will be used for local anesthesia of the cornea.

Time Frame

5 minutes

Title

Visual acuity

Description

Best-corrected visual acuity will be measured using the standard ETDRS acuity charts.

Time Frame

5 minutes

Title

Visual analogue scale (VAS) for patient satisfaction

Description

Patient satisfaction assessed by a VAS will be determined using a 100 mm VAS on which 0 means "I do not agree" and 100 means "I totally agree". The following questions will be assessed using VAS: "I feel satisfied using this treatment" "With these eye drops, I have a feeling of freshness" "With these eye drops, I have a feeling of relief" "This product contributed to reduce my pain due to eye dryness" "This product is comfortable"

Time Frame

5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age ≥ 18 years Normal ophthalmic findings except dry eye disease Ametropy ≤ 6 diopters Chronic dry eye defined as longer than six months since diagnosis OSDI ≥ 22 Conjunctival Hyperemia ≥ Grade 3 (Efron Scale) Current use of topical lubricants since at least 3 months Exclusion criteria: Best far corrected visual acuity < 1/10 Severe Dry Eye associated with: Eyelid malposition Sjogren Syndrome Steven Johnson Syndrome Corneal dystrophy Ocular neoplasia Filamentous keratitis Corneal neovascularisation Orbital radiotherapy History of any of the following within last 3 months: Systemic treatment of dry eye Systemic treatment of MGD Isotretinoide, Cyclosporine, Tacrolimus, Siromilus, Pimecrolimus Punctual plugs Anti-glaucoma treatment History of any of the following within previous six months: ocular trauma ocular infection, ocular allergy History of any of the following within last 12 months: inflammatory corneal ulcer Herpetic eye infection or uveitis Ocular surgery History of IOP increase caused by systemic or topical treatment with corticosteroids IOP > 22mmHg Glaucoma in the medical history Known hypersensitivity to any of the components of the IMP under investigation or other study medication Allergic rhinitis; active or susceptible to reactivation during the study Pregnant or breast-feeding woman. Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intrauterine device, contraceptive implant or condoms) Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent. Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) Participation in another clinical study or clinical investigation at the same time as the present investigation Participation to the present clinical investigation during the exclusion period of another clinical study Patient already included once in this clinical investigation Patient under guardianship

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

31741283

Citation

Kallab M, Szegedi S, Hommer N, Stegmann H, Kaya S, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial. Adv Ther. 2020 Jan;37(1):329-341. doi: 10.1007/s12325-019-01137-8. Epub 2019 Nov 18. Erratum In: Adv Ther. 2019 Dec 10;:

Results Reference

derived

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Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

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