Trial Outcomes & Findings for Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers (NCT NCT01339936)

Results Overview

The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10\^-7 g/cm\^2 /s and recorded for relative humidity of 25% to 35%.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

40 participants

Primary outcome timeframe

after 30 days of eyedrop usage

Results posted on

2013-11-28

Participant Flow

The subjects were selected from the existing clinical population of Optometric Technology Group Ltd (OTG Research \& Consultancy). The subjects, fulfilling the criteria for inclusion were invited in a random fashion to participate in the study until the test population was achieved.

Participant milestones

Participant milestones
Measure	Investigational Eye Drop Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
Overall Study STARTED	38
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Eye Drop n=35 Participants Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	49 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United Kingdom	35 participants n=5 Participants

PRIMARY outcome

Timeframe: after 30 days of eyedrop usage

Population: The analysis was carried out on subjects having completed the study according to the protocol e.g. 35

The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10\^-7 g/cm\^2 /s and recorded for relative humidity of 25% to 35%.

Outcome measures

Outcome measures
Measure	Investigational Eye Drop n=35 Participants Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
Tear Film Evaporation Rate	26.0 10^-7g/cm^2/sec Standard Deviation 11.2

SECONDARY outcome

Timeframe: after 30 days of eyedrop usage

Population: The analysis was carried out on subjects having completed the study according to the protocol e.g. 35

The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis.

Outcome measures

Outcome measures
Measure	Investigational Eye Drop n=35 Participants Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
Tear Break Up Time	5.8 seconds Standard Deviation 4.3

SECONDARY outcome

Timeframe: after 30 days of eye drop usage

The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient's ability to function. The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability.

Outcome measures

Outcome measures
Measure	Investigational Eye Drop n=35 Participants Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
Ocular Surface Disease Index Score	26.8 points Standard Deviation 23.0

Adverse Events

Investigational Eye Drop

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Investigational Eye Drop n=36 participants at risk Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
Eye disorders Stye	2.8% 1/36 • Number of events 1
Skin and subcutaneous tissue disorders Allergic response	2.8% 1/36 • Number of events 1
Surgical and medical procedures Bunion surgery	2.8% 1/36 • Number of events 1

Additional Information

Dr Michel Guillon

Optometric Technology Group

Phone: +44 2072224224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication policy The investigation data is wholly owned by the Sponsor. The results of the investigation may not be used in publications or presentations without the written permission of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER