Dry Eye SyndromeNCT00893243
Efficacy Comparative Study Between Tears Again®, Opticol® and Optive®
An observational study of Dry Eye Syndrome, run by Hospital de Sao Sebastiao at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- How many people
- 27 participants
- Where
- 1 sitePortugal
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Administrative staff of the hospital with more than 4 hours/day computer use and contact lens wearers
Who may be able to join
- Informed Consent signed
- Age >18 years and < 55 years
- Daily wearer of soft contact lens and/or daily (> 4 hours/day) computer user
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Serviço de Oftalmologia, Hospital de São Sebastião
Santa Maria da Feira, 4520-211
About this study
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
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
- Conditions
- Dry Eye Syndrome
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1Tears Again/Control | Not described | |
| 2Opticol/Control | Not described | |
| 3Optive/Control | Not described | |
| 4Tears Again/Opticol | Not described | |
| 5Tears Again/Optive | Not described | |
| 6Opticol/Optive | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Sao Sebastiao
- Sponsor type
- University, hospital or other
- Investigators
- Lilianne Duarte, MD, Principal investigator, OphthalmologistJosé Salgado-Borges, PhD, Study director, Ophthalmology Department Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893243
- Sponsor's protocol ID
- HSS-01-08
- Status last verified
- May 2009
- First submitted
- 4 May 2009
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00893243
- Acronym / sponsor ID
- HSS-01-08
- Conditions
- Dry Eye Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hospital de Sao SebastiaoUniversity, hospital or other
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1Tears Again/Control | – | – |
| 2Opticol/Control | – | – |
| 3Optive/Control | – | – |
| 4Tears Again/Opticol | – | – |
| 5Tears Again/Optive | – | – |
| 6Opticol/Optive | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Administrative staff of the hospital with more than 4 hours/day computer use and contact lens wearers
Key inclusion criteria (3 listed)
- Informed Consent signed
- Age >18 years and < 55 years
- Daily wearer of soft contact lens and/or daily (> 4 hours/day) computer user
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilianne Duarte, MD principal investigator
Ophthalmologist
José Salgado-Borges, PhD study director
Ophthalmology Department Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndrome, run by Hospital de Sao Sebastiao at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2009.