Efficacy Comparative Study Between Tears Again®, Opticol® and Optive®
Sponsor
Hospital de Sao Sebastiao (Other)
Overall Status
Completed
CT.gov ID
NCT00893243
Collaborator
(none)
27
1
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
27 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Efficacy Comparative Study Between Tears Again®, o Opticol® e o Optive® in Clinical and Symptomatology Treatment of Dry Eye Syndrome in Contact Lens Wearers and/or Computers Users
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1Tears Again/Control
|
|
| 2Opticol/Control
|
|
| 3Optive/Control
|
|
| 4Tears Again/Opticol
|
|
| 5Tears Again/Optive
|
|
| 6Opticol/Optive
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Informed Consent signed
-
Age >18 years and < 55 years
-
Daily wearer of soft contact lens and/or daily (> 4 hours/day) computer user
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Serviço de Oftalmologia, Hospital de São Sebastião | Santa maria da Feira | Portugal | 4520-211 |
Sponsors and Collaborators
- Hospital de Sao Sebastiao
Investigators
- Principal Investigator: Lilianne Duarte, MD, Ophthalmologist
- Study Director: José Salgado-Borges, PhD, Ophthalmology Department Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00893243
Other Study ID Numbers:
- HSS-01-08
First Posted:
May 5, 2009
Last Update Posted:
May 5, 2009
Last Verified:
May 1, 2009