N/A N=15 Diagnostic

Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation

Aqueous Deficient Dry Eye · Meibomium Gland Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT01128049 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: Primary: Visual Quality — 0.3; 0.32; 0.19; 0.3 microns

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Subjective Questionnaire (Behavioral); Measurement with wavefront sensor (right eye, then left eye) (Procedure); Instill Saline Drop (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Quality	0.3; 0.32; 0.19; 0.3; 0.33; 0.23	—

Summary

Compare the objective tear film dynamic measurements in three different populations (MGD [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry eye]) and the subjective experience before and after instilling a single drop of saline in each eye. Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.

Eligibility Criteria

General Inclusion Criteria:

Good general Health
The subject must appear able and willing to adhere to the instructions set forth in this protocol (such as not use warm compresses or artificial tears/lubricant or excessive eye makeup before the visit on the study day).

General Exclusion Criteria:

Ocular disease, infection or inflammation (allergy, blepharitis) that is clinically significant (grade 3 or 4) that in the opinion of the PI would not be a good subject.
Systemic disease or use of medication that in the opinion of the PI would not be a good subject.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
Contact lens wearer.
Pregnancy or lactation.
Diabetes.
Inclusion or exclusion criteria of the other cohorts.

Cohort Specific Inclusion Criteria:

ADDE cohort: Schirmer I < 10 mm, BUT ¬< 5 seconds, Fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally.
MGD cohort: Diagnosis of moderate or severe MGD
Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01128049). 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.