Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
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.


Options:
A: Inclusion Criteria:

* Between the ages of 30 and 80 inclusive.
* Has not worn contact lenses for at least 1 month prior to the study and agrees to not wear contact lenses during study.
* Oral medications stable 1 month prior to study.
* Oral medications anticipated to be stable during 60 day study.
* Patient is in generally good \& stable overall health.
* Patient likely to comply with eye drop regimen, study guidelines \& study visits.
* Corneal stain \> 1+ or Conjunctival stain \> 1+ or OSDI equal or \> 5 or using regular artificial tears at least on average twice daily.
* Informed consent signed.

Exclusion Criteria:

* History of Stevens-Johnson Syndrome or Ocular Pemphigoid.
* Punctal plugs inserted or punctal cautery in the past 3 months.
* Intra-ocular surgery within 6 months or ocular laser surgery within 3 months.
* History of liver disease.
* Pregnant or lactating women.
* Severe clinical vitamin deficiencies or history of vitamin overdose.
* Highly variable vitamin intake.
* Unstable use of systemic or topical medications known to create dry eye.
* Corneal pathology, which could, of itself, cause an ocular surface disorder.
* Use of glaucoma medications, topical or oral.
* Unstable diabetes mellitus.
* Allergy or sensitivity to Lotemax, Restasis or the OTC Tear Supplement.
* Use of topical steroids or Restasis within the past 1 month.
* Use of other topical ocular agents other than tear replacements within the past 1 week.
B: Inclusion Criteria:

(1) stage 3 or 4 meibomian gland dysfunction

Exclusion Criteria:

1. history of previous ocular or intraocular surgery
2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
3. history of intolerance or hypersensitivity to any component of the study medications,
4. wearing contact lenses during the study period, presence of current punctal occlusion,
5. pregnancy, lactating women, and children.
6. Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears
C: Inclusion Criteria:

• Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

* Known hypersensitivity/contraindication to study product(s) or components.
* History of glaucoma, IOP \>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
* Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening.
* In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
D: 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

Answer: D