Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Patients with Dry Eye Disease (DED) who have been treated with 1% CMC Eye Drops *

Yes No

Signs and Symptoms *

Clinical Diagnosis *

Stage of Endometriosis*

Duration and severity of current illness *

Symptoms Severity *	No (0) *	Mild (1) *	Moderate (2) *	Severe (3) *
Pain
Dryness
Irritation
Poor vision
Sensitivity to light

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

1% CMC Eye Drops prescribed*

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy (days) *

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Signs and Symptoms (if any)

Symptoms Severity *	No (0) *	Mild (1) *	Moderate (2) *	Severe (3) *
Pain
Dryness
Irritation
Poor vision
Sensitivity to light

Tear Break-UP Time (TBUT) *

Adverse events noted due to study medication *

Yes No

ADVERSE EVENT(S)
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Severity	Action Taken	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1					Yes No			Yes No
2					Yes No			Yes No
3					Yes No			Yes No
4					Yes No			Yes No
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If 'Treatment given 'is ticked as 'Yes' then relevant information should be captured on Prior and concomitant Medication Form. Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

CMC in DED

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

VITALS

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - POST TREATMENT FOLLOW-UP (after 1-3 MONTHS)

DATE OF ASSESSMENT

VITALS

CLINICAL DATA

ADVERSE EVENTS