NCT00893243

Brief Summary

Primary Purpose:

  • To compare the efficacy in treating dry eye syndrome in contact lens wearers or computer users of Tears Again® versus Opticol® versus Optive® Secondary Purpose:
  • Subjective evaluation of symptomatology
  • Evaluation of preference in different kind of administration - spray versus monodoses versus multi-doses

Trial Health

80
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

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

First Submitted

Initial submission to the registry

May 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

First QC Date

May 4, 2009

Last Update Submit

May 4, 2009

Conditions

Dry Eye Syndrome

Study Arms (6)

1Tears Again/Control

2Opticol/Control

3Optive/Control

4Tears Again/Opticol

5Tears Again/Optive

6Opticol/Optive

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Administrative staff of the hospital with more than 4 hours/day computer use and contact lens wearers

You may qualify if:

  • Informed Consent signed
  • Age \>18 years and \< 55 years
  • Daily wearer of soft contact lens and/or daily (\> 4 hours/day) computer user

You may not qualify if:

  • Dry eye Syndrome other than of evaporative etiology, according to DEWS
  • Ocular or systemic disease that can affect the normal tear film
  • Pregnancy or pregnancy risk (no contraceptive method), lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serviço de Oftalmologia, Hospital de São Sebastião

Santa Maria da Feira, 4520-211, Portugal

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Lilianne Duarte, MD

    Ophthalmologist

    PRINCIPAL INVESTIGATOR

  • José Salgado-Borges, PhD

    Ophthalmology Department Director

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 5, 2009

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

PT(1)