NCT04536129

Brief Summary

Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

August 27, 2020

Last Update Submit

September 30, 2021

Conditions

Ocular Surface DiseaseGlaucoma

Outcome Measures

Primary Outcomes (2)

  • Intraocular pressure(IOP)

    IOP evaluation at time zero (T0), after 1 (T1) and two weeks of therapy (T2).

    2 weeks

  • OSDI (Ocular Surface Disease Index) questionnaire

    OSDI record at time zero (T0), after 1 (T1) and two weeks of therapy (T2).

    2 weeks

Study Arms (2)

Group A: glaucoma

EXPERIMENTAL

OSD patients with glaucoma

Drug: Hydrocortisone (CORTIVIS ®)

Group B: no glaucoma

ACTIVE COMPARATOR

OSD patients without glaucoma

Drug: Hydrocortisone (CORTIVIS ®)

Interventions

Hydrocortisone (CORTIVIS ®)DRUG

Once enrolled all the patients had to instill topical low dose (1,005 mg) preservative-free hydrocortisone (CORTIVIS ®- Medivis, Catania, Italy) 2 times daily in each eye for two weeks.

Group A: glaucomaGroup B: no glaucoma

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age of at least 18 years
  • diagnosis of OSD (Ocular Surface Disease)
  • normal ophthalmic findings except history of OSD for at least 3 months, and current therapy with topical lubricants for at least 3 months
  • POAG (primary open-angle glaucoma ) patients on medical therapy

You may not qualify if:

  • clinically significant slit lamp findings at screening visit except OSD
  • participation in a clinical trial in the 4 weeks preceding the screening visit
  • symptoms of a clinically relevant illness in the 3 weeks before the screening visit
  • presence/ history of a severe medical or surgical condition
  • intake of parasympathomimetic or antipsychotic drugs
  • wearing of contact lenses
  • previous refractive laser surgery (e.g photorefractive keratectomy-PRK, laser assisted in situ keratomileusis-LASIK, etc.)
  • history of IOP increase caused by systemic or topical treatment with corticosteroids
  • IOP greater than 22 mmHg
  • treatment with corticosteroids in the 4 weeks preceding the study
  • types of glaucoma other than POAG
  • ocular infection or clinically significant inflammation
  • ocular surgery in the 3 months preceding the study
  • Sjögren's syndrome, Stevens-Johnson syndrome
  • history of allergic conjunctivitis
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Molise

Campobasso, Italy

Location

Related Publications (8)

  • Khanna RC. Ocular surface disorders. Community Eye Health. 2017;30(99):S1-S2. No abstract available.

    PMID: 29849435RESULT

  • Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8.

    PMID: 28797892RESULT

  • Lanza M, Gironi Carnevale UA, Mele L, Bifani Sconocchia M, Bartollino S, Costagliola C. Morphological and Functional Evaluation of Oral Citicoline Therapy in Chronic Open-Angle Glaucoma Patients: A Pilot Study With a 2-Year Follow-Up. Front Pharmacol. 2019 Sep 26;10:1117. doi: 10.3389/fphar.2019.01117. eCollection 2019.

    PMID: 31611797RESULT

  • Mohammed I, Kulkarni B, Faraj LA, Abbas A, Dua HS, King AJ. Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: A 2-year randomized evaluation study. Clin Exp Ophthalmol. 2020 Sep;48(7):973-982. doi: 10.1111/ceo.13814. Epub 2020 Jul 27.

    PMID: 32564453RESULT

  • Rossi GC, Pasinetti GM, Scudeller L, Bianchi PE. Ocular surface disease and glaucoma: how to evaluate impact on quality of life. J Ocul Pharmacol Ther. 2013 May;29(4):390-4. doi: 10.1089/jop.2011.0159. Epub 2012 Dec 7.

    PMID: 23215770RESULT

  • Rossi GC, Pasinetti GM, Scudeller L, Raimondi M, Lanteri S, Bianchi PE. Risk factors to develop ocular surface disease in treated glaucoma or ocular hypertension patients. Eur J Ophthalmol. 2013 May-Jun;23(3):296-302. doi: 10.5301/ejo.5000220. Epub 2012 Dec 17.

    PMID: 23335308RESULT

  • Kallab M, Szegedi S, Hommer N, Stegmann H, Kaya S, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Correction to: 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):342-343. doi: 10.1007/s12325-019-01190-3.

    PMID: 31823206RESULT

  • Filippelli M, dell'Omo R, Gelso A, Rinaldi M, Bartollino S, Napolitano P, Russo A, Campagna G, Costagliola C. Effects of topical low-dose preservative-free hydrocortisone on intraocular pressure in patients affected by ocular surface disease with and without glaucoma. Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):247-253. doi: 10.1007/s00417-021-05345-3. Epub 2021 Aug 18.

    PMID: 34406502DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor in Ophthalmology

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 2, 2020

Study Start

November 4, 2019

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

IT(1)