Search / Trial NCT06616922

Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults

Launched by NTC SRL · Sep 25, 2024

Trial Information

Current as of October 03, 2024

Completed

Keywords

Rd03/2016 Levofloxacin

Description

This study will enroll 252 patients with clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score ≥ 2 for each cardinal sign, i.e., bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge). Enrolled patients will attend three study visits: baseline (Day 0), On-Therapy (OT; Day 3-4) and final visit (Day 7-9). The duration of the study for each patient will be 7-9 days. Enrolled patients will undergo the following assessments: anamnesis; ophthalmological examination; swab of the lower conjunctiva for bacteriological examinatio...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Ability of patient to consent and provide signed written informed consent
  • 2. Male or female aged ≥ 18 year.
  • 3. Clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score ≥ 2 for each cardinal signs, i.e. bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge, in at least one eye), not previously treated with antibiotics, steroids and nonsteroidal anti-inflammatory drugs (NSAIDs).
  • 4. Able and willing to follow study procedures.
  • 5. Availability of a person (a relative or a caregiver) to be trained for the execution of the photographic documentation required by the study and for the use of eyePRO.net.
  • 6. Willing to interrupt the use of contact lenses for the entire duration of the study.
  • Exclusion Criteria:
  • 1. Any acute ocular clinical disease other than bacterial conjunctivitis.
  • 2. Any ocular surgery (including laser treatment) in the study eye within 30 days prior to study entry.
  • 3. Any ocular (in the study eye) or systemic antimicrobial agents administered concurrently or within 3 days prior to study entry.
  • 4. Any ocular (in the study eye) or systemic steroids or NSAIDs administered concurrently.
  • 5. Pathological conditions or treatments that in the opinion of the Investigator may interfere with the efficacy and/or safety evaluations of the study (e.g. chronic blepharitis, glaucoma, moderate-severe dry eye).
  • 6. Participation in previous clinical studies if less than 5 half-lives of the Investigational Medicinal Product (IMP) used have passed.
  • 7. Hypersensitivity to the products, other quinolones, acetylsalicylic acid and other NSAIDs (due to potential for cross-sensitivity), or their excipients.
  • 8. Contraindications to ocular treatment with levofloxacin and/or ketorolac.
  • 9. Pregnancy or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline visit and practice effective contraceptive measures throughout the study.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Siena, , Italy

Roma, , Italy

San Giovanni Rotondo, , Italy

Verona, , Italy

Bergamo, , Italy

Milano, , Italy

Karlsruhe, , Germany

Bari, , Italy

Camaiore, , Italy

Carrara, , Italy

Catania, , Italy

Chiari, , Italy

Chieti, , Italy

Firenze, , Italy

Messina, , Italy

Milano, , Italy

Milano, , Italy

Milano, , Italy

Milano, , Italy

Milazzo, , Italy

Napoli, , Italy

Palermo, , Italy

Palermo, , Italy

Pisa, , Italy

Roma, , Italy

Roma, , Italy

Savigliano, , Italy

Treviso, , Italy

Ivanovo, , Russian Federation

Moscow, , Russian Federation

Moscow, , Russian Federation

Moscow, , Russian Federation

Omsk, , Russian Federation

Saint Petersburg, , Russian Federation

San Pietroburgo, , Russian Federation

Yaroslavl, , Russian Federation

Madrid, , Spain

Marbella, , Spain

Valencia, , Spain

Valladolid, , Spain

Vigo, , Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0