NCT01799863

Brief Summary

The purpose of this study is to evaluate the evolution of the symptoms of acute viral conjunctivitis using preservative free ketorolac trometamol 0.45% associated with carboxymethylcellulose compared with isolated use of preservative-free artificial tears.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

February 22, 2013

Last Update Submit

April 7, 2015

Conditions

Conjunctivitis, Viral

Keywords

Conjunctivitis, ViralKetorolacArtificial tears

Outcome Measures

Primary Outcomes (2)

  • Change in ocular symptoms from baseline to treatment day 7

    General ocular discomfort, itching, foreign body sensation, tearing, eye redness and eyelid edema. Symptoms will be graded as 0 (absence), I (mild), II (moderate) and III (severe).

    7 days

  • Change in ocular signs from baseline to treatment day 7

    The clinical examination will consist of slit-lamp examination of the anterior segment. Four signs will be assessed: conjunctival hyperemia, chemosis, secretion and follicles in lower tarsal conjunctiva. The signs will be classified as 0 (absence), I (mild), II (moderate), III (severe)

    7 days

Study Arms (2)

Ketorolac trometamol 0.45%

EXPERIMENTAL

Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.

Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose

Artificial tears

PLACEBO COMPARATOR

Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.

Drug: Preservative free artificial tear

Interventions

Ketorolac trometamol 0.45% with carboxymethylcelluloseDRUG
Also known as: Acular CMC®, Allergan, Irvine, USA
Ketorolac trometamol 0.45%
Preservative free artificial tearDRUG
Also known as: Optive UD®, Allergan, Irvine, USA
Artificial tears

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute conjunctivitis (unilateral or bilateral) for less than two weeks,
  • Signs and symptoms consistent with viral conjunctivitis and at least one of the following: preauricular lymphadenopathy, upper tract respiratory infection or recent contact with someone with conjunctivitis

You may not qualify if:

  • pregnant women
  • allergies to non-steroidal anti-inflammatories
  • history of seasonal allergic conjunctivitis
  • contact lens wearers
  • history of ocular herpes infection
  • blepharitis
  • severe dry eye
  • purulent discharge
  • defects in the corneal epithelium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundação Altino Ventura

Recife, Pernambuco, 50070040, Brazil

Location

Related Publications (2)

  • Shiuey Y, Ambati BK, Adamis AP. A randomized, double-masked trial of topical ketorolac versus artificial tears for treatment of viral conjunctivitis. Ophthalmology. 2000 Aug;107(8):1512-7. doi: 10.1016/s0161-6420(00)00177-9.

    PMID: 10919900BACKGROUND

  • Toker MI, Erdem H, Erdogan H, Arici MK, Topalkara A, Arslan OS, Pahsa A. The effects of topical ketorolac and indomethacin on measles conjunctivitis: randomized controlled trial. Am J Ophthalmol. 2006 May;141(5):902-905. doi: 10.1016/j.ajo.2005.12.004. Epub 2006 Mar 9.

    PMID: 16527227BACKGROUND

MeSH Terms

Conditions

Conjunctivitis, Viral

Interventions

KetorolacCarboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsVirus DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates

Study Officials

  • Adriana Falcão, MD

    Fundação Altino Ventura

    PRINCIPAL INVESTIGATOR

  • Lucio Maranhão, MD

    Fundação Altino Ventura

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2013

First Posted

February 27, 2013

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

BR(1)