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AzTrials

KeratitisPhase 3NCT05689996

Ozone-based Eye Drops as Adjuvant Therapy in Microbial Keratitis

A Phase 3 study testing Ozone-Based Agent in people with Keratitis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis . The therapeutic response will be evaluated with clinical examination follow up . Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Keratitis
What is being tested?
Ozone-Based Agent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2023to 1 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patients with active microbial keratitis ( bacterial , viral or fungal )
  • with positive culture and sensitivity result
  • Any age group.
  • accepting well informed consent for using the ozone eye drops

Who cannot join

  • patients refuse to participate
  • Patients with other forms of keratitis rather than infective keratitis . patients who will not complete treatment .

Trial locations and contacts

No sites are listed yet.

Abeer Abdel-Fattah contact

1064464974

abeerabdelfattah1@yahoo.com

About this study

Official title: Effect of Using of Ozone-based Eye Drops as Adjuvant Therapy in the Management of Microbial Keratitis in Comparison to the Conventional Therapy

To compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis . The therapeutic response will be evaluated with clinical examination follow up .

Read the detailed description

Inflammatory corneal diseases remain a major challenge in ophthalmology , for example microbial keratitis still remains a serious cause of corneal opacity and subsequently visual impairment worldwide [1,2,3 ]. Rarely the infection occurs in the normal eye as the human cornea has its natural resistance against infection. However, predisposing factors such as pre-existing corneal disease, contact lens wear , aggressive topical antimicrobial therapy , prior ocular surgery , ocular surface disease, and trauma may change the defense mechanisms of the ocular surfaces and thereafter permit entry of different pathogens. Treatment aims to managing any other associated ocular surface disease involvement, removing any known risk factors in addition to antimicrobial therapy . The patient requires close treatment response monitoring, sometimes including hospitalization followed by frequent outpatient visits. The risk of developing microbial keratitis and the severity of the disease depend on both the type of the infecting organism and the condition of the ocular surface .[4] .It is important to confirm infection in order to determine the most effective treatment, especially at the initial stage when the treatment is not based on culture results. Microbial keratitis is treated by topical eye drops containing anti-inflammatory and anti- bacterial agents. The current antimicrobial treatments often lack efficacy because infections occur in hypoxic tissue contain methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa so new products for the treatment of ocular inflammation and pain are needed. In addition, Increased bacterial antibiotic resistance contributes to the use of a therapy based on natural products, such as ozonized oil, which have a wide spectrum of antimicrobial effects for therapeutic applications.

The use of ozone in anterior segment pathologies could be providential due to its anti-inflammatory and bactericidal activity by direct oxidation mediated by lipoperoxyde and hydrogen peroxide, selective cytotoxicity on fast dividing cells, through bacterial lysis then cell death and negative regulation on mitochondrial activity in bacteria.[5] .Ozone dose trigger several useful biochemical mechanisms and reactivate the antioxidant system (i.e., catalase, superoxide dismutase, glutathione peroxidase, etc.) [ 6] in addition to promoting tissue repair properties , assumed to be due to the upregulation of platelet-derived growth factor, transforming growth factor-β, and vascular endothelial growth factor expressions. Eye drops containing ozone were recently used in the management of ocular surface infection caused by bacteria, viruses and fungi, [ 7-9] and a specific formulation containing liposomal ozonated sunflower oil (Ozodrop®, FB Vision, San Benedetto del Tronto, Italy) that is well tolerated by the ocular surface has been developed. [ 10 ] Ozone in the gaseous state is extremely reactive and not always suitable as a topical treatment. In saline solution, its concentration reduces quickly with a first-order kinetics and its half-life is 2 h: this means that in about 24 h very little ozone will be remains in the solution . In spite of its instability, the ozone molecule can be stabilized - for topical use - as an ozonide, an organic analog of ozone, formed by the reaction of ozone with an unsaturated fatty acid , such as oleic acid [ 12-11] . The zone eye drops will be used at regimen of 3 times per day in addition of antibiotics eye drops.

To superintend its effectiveness in dealing with microbial keratitis , assessment of visual acuity outcome , clinical examination , a follow up imaging from slit lamp will be done and an imaging modality as Anterior segment optical coherence tomography (ASOCT ) can be done . ASOCT is a relatively new imaging modality in the imaging field towards a better evaluation, diagnosis and management of many anterior segment diseases [13,14] .Current uses of ASOCT are corneal thickness evaluation , depth of corneal deposits and lesions including dystrophies, details of corneal inflammation, dry eye evaluation and diagnosis of surface neoplasia in early stages [ 15].Its purpose in this study is to describe the ASOCT cornea features during active stage of microbial keratitis and to evaluate its contribution for its diagnosis and the follow-up Images acquired by AS OCT will be compared to the clinical assessment .

Conditions
Keratitis
Being tested
Ozone-Based Agent
Keywords
Microbial keratitis
Medical subject headings
Keratitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ozone-Based AgentDrug

    Also called ozone-based eye drops

    Ozone-based eye drops as adjuvant therapy in microbial keratitis

Study groups in NCT05689996
Study groupRoleWhat they receive
Infective keratitisExperimentalPreparation of nanostructure lipid carriers (NLCs): The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported [1]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions.
Receives: Drug: Ozone-Based Agent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ozone-based eye drops as adjuvant therapy in microbial keratitis

    compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis.

    Main outcome measurements include decrease in size, depth and infiltrate of the ulcer in millimeters measured on slit lamp biomicroscopy .

    Measured: at 48 hours , 2-3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study startJan 2023 (estimated)
  3. Primary completionApr 2023 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Preparation of nanostructure lipid carriers (NLCs): The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported \[1\]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05689996
Sponsor's protocol ID
Ozone-based eye drops
Status last verified
Jan 2023
First submitted
11 Oct 2021
Last updated
19 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Spadea L, Tonti E, Spaterna A, Marchegiani A. Use of Ozone-Based Eye Drops: A Series of Cases in Veterinary and Human Spontaneous Ocular Pathologies. Case Rep Ophthalmol. 2018 May 24;9(2):287-298. doi: 10.1159/000488846. eCollection 2018 May-Aug.

    PubMed 29928225
  • Paduch R, Urbanik-Sypniewska T, Kutkowska J, Choragiewicz T, Matysik-Wozniak A, Zweifel S, Czarnek-Chudzik A, Zaluska W, Rejdak R, Toro MD. Ozone-Based Eye Drops Activity on Ocular Epithelial Cells and Potential Pathogens Infecting the Front of the Eye. Antioxidants (Basel). 2021 Jun 16;10(6):968. doi: 10.3390/antiox10060968.

    PubMed 34208703
  • Passidomo F, Pignatelli F, Addabbo G, Costagliola C. Topical Liposomal Ozonated Oil in Complicated Corneal Disease: A Report on Three Clinical Cases. Int Med Case Rep J. 2021 May 14;14:327-332. doi: 10.2147/IMCRJ.S311839. eCollection 2021.

    PubMed 34017203
  • Sridhar MS, Martin R. Anterior segment optical coherence tomography for evaluation of cornea and ocular surface. Indian J Ophthalmol. 2018 Mar;66(3):367-372. doi: 10.4103/ijo.IJO_823_17.

    PubMed 29480245

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ozone-Based Agent in people with Keratitis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abeer Abdel-Fattah (1064464974, abeerabdelfattah1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ozone-based eye drops as adjuvant therapy in microbial keratitis (time frame: at 48 hours , 2-3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05689996, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.

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