Trial Outcomes & Findings for Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics (NCT NCT01450787)

Results Overview

Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.

Recruitment status

TERMINATED

Target enrollment

63 participants

Primary outcome timeframe

at the time of the evaluation

Results posted on

2013-09-30

Participant Flow

Subjects were enrolled randomly. Consecutive patients in a private ophthalmology clinic that met inclusion criteria were asked to participate at the time of an already scheduled exam. The non-diabetic group recruitment stopped once the target number of subjects enrolled. The diabetic group recruitment continued until the study was terminated.

Being that there was no intervention and the study only involved taking measurements at the time of the exam, there was no transition required. Any eligible patient that was willing to participate was included. Consecutive diabetic patients and consecutive non-diabetic patients that met criteria were offered the opportunity to enroll.

Participant milestones

Participant milestones
Measure	Diabetics diabetics over age 40	Non Diabetics non diabetics over age 40
Overall Study STARTED	38	25
Overall Study COMPLETED	38	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetics n=38 Participants diabetics over age 40	Non Diabetics n=25 Participants non diabetics over age 40	Total n=63 Participants Total of all reporting groups
Age, Customized	38 participants n=5 Participants	25 participants n=7 Participants	63 participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	4 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	25 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: at the time of the evaluation

Population: There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.

Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.