Phase 3
N=38
Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01339936 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Tear Film Evaporation Rate — 26.0 10^-7g/cm^2/sec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Carboxymethylcellulose sodium, glycerin and polysorbate 80 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Optometric Technology Group Ltd
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Film Evaporation Rate |
26.0 | — |
| SECONDARY Tear Break Up Time |
5.8 | — |
| SECONDARY Ocular Surface Disease Index Score |
26.8 | — |
Summary
The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.
Eligibility Criteria
Inclusion Criteria
- Mild or greater dry eye symptoms.
- Evidence of evaporative dry eye
Exclusion Criteria
- Known allergy or sensitivity to the study product(s) or its components
- Current contact lens wearer
- Systemic or ocular allergies
- Use of systemic medication which might have ocular side effects.
- Any ocular infection.
- Use of ocular medication.
Data sourced from ClinicalTrials.gov (NCT01339936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.