Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:13 AM
Study NCT ID:
NCT07394257
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003320', 'term': 'Corneal Ulcer'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization will be performed using a computer-generated random sequence. Allocation will be concealed using sealed opaque envelopes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-01', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-02-01', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete clinical resolution(days)', 'timeFrame': 'weekly till complete healing', 'description': 'Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction.'}], 'secondaryOutcomes': [{'measure': '• Epithelial defect size(mm)', 'timeFrame': 'weekly for one month', 'description': 'epithelial defect is measured by surgical caliper'}, {'measure': 'Hypopyon height(mm).', 'timeFrame': 'weekly for one month'}, {'measure': 'Pain score on visual Analog scale (VAS, 1 - 10).', 'timeFrame': 'weekly for one month'}, {'measure': 'Best-corrected visual acuity (BCVA) (LogMAR or Snellen)', 'timeFrame': 'weekly for one month'}, {'measure': 'Complications (perforation, thinning, endophthalmitis).', 'timeFrame': 'after 3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Keratitis', 'Recalcitrant Infectious Keratitis', 'Corneal Ulcer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zemba M, et al. Intrastromal injections in infectious keratitis. Pharmaceutics. 2023'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.ophtha.2006.12.011', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Bacterial keratitis is a potentially sight-threatening corneal infection that is commonly treated with intensive topical antibiotics. Despite appropriate therapy, some cases show inadequate clinical response, particularly when the infection involves the deep corneal stroma. Limited penetration of topical antibiotics into deeper corneal layers may contribute to treatment failure in these recalcitrant cases.\n\nIntrastromal antibiotic injection is a targeted drug-delivery approach that allows high local antimicrobial concentrations directly at the site of infection. Moxifloxacin is a broad-spectrum fluoroquinolone with proven efficacy in bacterial keratitis and favorable corneal tissue penetration. However, evidence regarding the clinical benefit and safety of intrastromal moxifloxacin as an adjunctive treatment remains limited.\n\nThis randomized controlled trial aims to evaluate the efficacy and safety of intrastromal moxifloxacin injection as an adjunct to standard topical moxifloxacin therapy compared with topical therapy alone in patients with recalcitrant bacterial keratitis. The primary outcome is time to complete clinical resolution of infection. Secondary outcomes include visual acuity improvement, ulcer healing rate, need for additional interventions, and treatment-related complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age ≥ 18 years\n\n * Clinical diagnosis of bacterial keratitis confirmed by corneal scraping and microbiology\n * Recalcitrant keratitis defined as no significant clinical improvement after 48-72 hours of intensive topical antibiotic therapy\n * Ability to provide written informed consent\n\nExclusion Criteria\n\n* Fungal, viral, or acanthamoeba keratitis\n* Corneal perforation or impending perforation\n* Known hypersensitivity to fluoroquinolones\n* Pregnancy or lactation\n* Immunocompromised state or current systemic immunosuppressive therapy\n* Previous intrastromal or intracameral antibiotic injection for the same episode'}, 'identificationModule': {'nctId': 'NCT07394257', 'briefTitle': 'Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis', 'orgStudyIdInfo': {'id': '1827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy', 'description': 'Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.', 'interventionNames': ['Drug: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Standard topical moxifloxacin therapy alone', 'description': '• Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response', 'interventionNames': ['Drug: Standard topical moxifloxacin therapy alone']}], 'interventions': [{'name': 'Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy', 'type': 'DRUG', 'description': 'Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.', 'armGroupLabels': ['Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy']}, {'name': 'Standard topical moxifloxacin therapy alone', 'type': 'DRUG', 'description': 'Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.', 'armGroupLabels': ['Standard topical moxifloxacin therapy alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Mahmoud Ramadan Amer', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Mahmoud Ramadan Amer, MD', 'role': 'CONTACT', 'email': 'mahmoud3mer89@gmail.com', 'phone': '0201068005575'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '(IPD) will not be shared because the study was not designed with a data-sharing framework, and participants did not provide explicit consent for secondary use or external sharing of their individual-level data. In addition, sharing IPD may pose potential risks to participant privacy, even after de-identification, particularly in single-center studies with limited sample sizes. Current clinical trial registration requirements mandate transparency regarding data-sharing intentions but do not obligate investigators to share IPD. Therefore, the decision not to share IPD is made in accordance with ethical standards, privacy regulations, and applicable registry policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of ophthalmology', 'investigatorFullName': 'Mahmoud Ramadan', 'investigatorAffiliation': 'Minia University'}}}}