Trial Outcomes & Findings for Effects of Anti-Glaucoma Medications on the Ocular Surface (NCT NCT01315574)

Results Overview

Applanation tonometry will be used to measure patients' intraocular pressure

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

At the 6 month follow-up time point

Results posted on

2017-03-16

Participant Flow

Participants recruited from May 2011 to June 2013

Participant milestones

Participant milestones
Measure	Latanoprost (Xalatan) 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.	Travoprost (Travatan Z) 7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma. Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Anti-Glaucoma Medications on the Ocular Surface

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Latanoprost (Xalatan) n=7 Participants 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.	Travoprost (Travatan Z) n=7 Participants 7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma. Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.	Total n=14 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 7.9 • n=93 Participants	68.3 years STANDARD_DEVIATION 10.0 • n=4 Participants	66.8 years STANDARD_DEVIATION 8.8 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	7 participants n=93 Participants	7 participants n=4 Participants	14 participants n=27 Participants
Central Corneal Dendritic Cell Density	126 cells/mm^2 STANDARD_DEVIATION 88 • n=93 Participants	91 cells/mm^2 STANDARD_DEVIATION 60 • n=4 Participants	109 cells/mm^2 STANDARD_DEVIATION 75 • n=27 Participants
Intraocular Pressure	21 mmHg STANDARD_DEVIATION 6 • n=93 Participants	22 mmHg STANDARD_DEVIATION 4 • n=4 Participants	21.5 mmHg STANDARD_DEVIATION 4.8 • n=27 Participants
Corneal Fluorescein Staining Score	0.6 units on a scale STANDARD_DEVIATION 1.1 • n=93 Participants	1.3 units on a scale STANDARD_DEVIATION 2.0 • n=4 Participants	0.9 units on a scale STANDARD_DEVIATION 1.6 • n=27 Participants
Tear Break-Up Time (TBUT)	7.9 seconds STANDARD_DEVIATION 2.0 • n=93 Participants	8.4 seconds STANDARD_DEVIATION 3.7 • n=4 Participants	8.1 seconds STANDARD_DEVIATION 2.9 • n=27 Participants

PRIMARY outcome

Timeframe: At the 6 month follow-up time point

Population: Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.

Applanation tonometry will be used to measure patients' intraocular pressure

Outcome measures

Outcome measures
Measure	Latanoprost (Xalatan) n=5 Participants 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.	Travoprost (Travatan Z) n=5 Participants 7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma. Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
Effectiveness in Lowering Intraocular Pressure	13.7 mmHg Standard Deviation 2.8	17.2 mmHg Standard Deviation 2.7

SECONDARY outcome

Timeframe: At the 6 month follow-up time point

Population: Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.

Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.

Outcome measures

Outcome measures
Measure	Latanoprost (Xalatan) n=5 Participants 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.	Travoprost (Travatan Z) n=5 Participants 7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma. Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
Corneal Fluorescein Staining Score	1 units on a scale (1-4) Standard Deviation 1.7	1.5 units on a scale (1-4) Standard Deviation 2.2

SECONDARY outcome

Timeframe: At the 6 month follow-up time point

Population: Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.

Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.

Outcome measures

Outcome measures
Measure	Latanoprost (Xalatan) n=5 Participants 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.	Travoprost (Travatan Z) n=5 Participants 7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma. Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
Tear Film Break-Up Time	6.3 Seconds Standard Deviation 1.7	6.7 Seconds Standard Deviation 3.9

Adverse Events

Latanoprost (Xalatan)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Travoprost (Travatan Z)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pedram Hamrah

Massachusetts Eye and Ear Infirmary

Phone: 617-573-6060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place