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Phase 3 N=534 Randomized Triple-blind Screening

Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

Allergic Conjunctivitis

Enrolled (actual)
534
Serious AEs
0.8%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Participants With at Least One Adverse Event. — 113; 34 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
KetoNaph (Drug); Vehicle (Drug)
Age
Pediatric, Adult, Older Adult · 2+ yrs
Sex
All
Sponsor
Bausch & Lomb Incorporated
Primary completion
Sep 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With at Least One Adverse Event.
113; 34

Summary

This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.

Eligibility Criteria

Inclusion Criteria

  • Subjects less than 18 years of age, have either a history or family history of ocular allergy.
  • ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.

Exclusion Criteria

  • Contraindications or sensitivities to the use of any of the investigational product(s) or their components.
  • Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1.
  • Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.
  • A known history of retinal detachment, diabetic retinopathy, or active retinal disease;
  • An active ocular infection (bacterial, viral or fungal
  • Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment.
  • Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment.
  • Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications.
  • Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01159015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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