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Clinical Trials/CTRI/2010/091/002953
CTRI/2010/091/002953CompletedPhase 1

A RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, PARALLEL-GROUPS,SINGLE DAY, DOSE ESCALATION STUDY TO ASSESS THE SAFETY, TOLERABILITY, ANDPHARMACOKINETICS OF COMPOUND 1334H OPHTHALMIC SOLUTION IN HEALTHYSUBJECTS

Sun Pharma Advanced Research Company Ltd0 sites32 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
32
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •Healthy male and female subjects, 18 to 45 years of age, subjects having weight at least 50Kg
  • •and the subjects body mass index (BMI) must be within 18.5 ? 25.0 (Kg/m2) (inclusive),Corrected Snellen visual acuity > 20/25 in both eyes,Intraocular pressure (IOP) < 21 mm Hg,Ability to tolerate vehicle eye drops to the satisfaction of study staff,Normal slit lamp biomicroscopy exam and dilated fundoscopic exam within 2 weeks of dosing,Willing to abstain from the concomitant use of ocular or systemic medication (excluding acetaminophen and multivitamins) from 2 weeks prior to start of study dosing until study
  • •completion,Willing to comply with scheduled visits, treatment plans, laboratory assessments and other study-related procedures,Women of child bearing potential practicing an acceptable method of birth control as judged by
  • •the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral
  • •or long acting injected contraceptives] from at least 2 months prior to study entry and through
  • •the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal
  • •ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a
  • •negative urine pregnancy test,Provide written informed consent to participate.

Exclusion Criteria

  • •History of ocular surgery, trauma, or chronic ocular disease,Current use of contact lenses or discontinuation of contact lens use less than 2 weeks of the first dosing day,Any ocular abnormalities or ocular symptoms,Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular
  • •agents during the study period,Alcohol dependence, alcohol abuse or drug abuse with any recreational drug within past one
  • •year,Smoking or consumption of tobacco products,Use of enzyme-modifying drugs in the previous 30 days before day 1 of this study,Systemic corticosteroid use within the past 6 months.

Investigators

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